FDA Device Recalls in 2025
72 recalls found
December 2025
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
NuMED sent a "URGENT: MEDICAL DEVICE RECALL" letter dated 4/21/2025 via email on 4/21/2025 to their single customer. The customer was instructed to immediately return the affected units as soon as possible. If you have any questions or concerns, please contact Regulatory Affairs Manager at (315) 328-4491, or via email at nlaflesh@numedusa.com.
CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System without Oxygen Regulator; d. CMI-0100-PNX-HSWM, Pro-Nox Hospital System Wall Mount with Universal Mount (GCX) scavenger; e. CMI-0100-PNX-NHS, Pro-Nox Complete Roll Stand Nitrous Oxide Delivery System (Non-hospital); f.
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
CAREstream Medical Ltd. notified its customers on or about 05/15/2015 via a Medical Device Product Correction letter. The letter informed customers to return their units, (model number: CMI-0100-PNX-xxx) for inspection and upgrade at the firms service center in Florida. So as to allow the customer's continued use of the devices safely during this process (and until all units are upgraded), CAREsteam recommends the device only be used with an oxygen monitor with alarms, attached to the device in accordance with our product manual (refer to Users Manual (revision 6) for instructions). Customers were also instructed to fax or email CAREstream Medical Ltd. to acknowledge receipt of the Medical Device Product Correction letter.
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
bioMerieux notified customers on about 03/01/2018, via letter. Instructions included to distribute the recall information to all appropriate personnel in the laboratory, forward the information to individuals to which the product many have been transferred to, destroy any impacted lots on site, and complete and return the Acknowledgement Form. Questions and concerns can be directed to local bioMerieux Customer Service representatives or for Clinical Technical Support Center by email at CustomerService-ImmunoMolecular@biomerieux.com.
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
Invalid calibration with low calibrator S1 while using the product.
The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
November 2025
September 2025
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory.
Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, a
Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.
Consignees were notified via mail on 11/13/2017, 01/09/2018, and 02/12/2018, as a result of expansions of the recall and the need to provide additional instructions and information to consignees. Instructions in the first letter date 11/13/2017 instructed customers to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to utilize the enclosed Reference Tool when verifying syringe size, and to complete the return the Response Form. Instructions in the letter dated 01/09/2018 included to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to advise all clinicians overseeing use of the affected devices to utilize the enclosed Reference Tool, to remove the pump if the syringe is not recognized or is read as an incorrect size during programming or infusion, to notify impacted customers if the devices were further distributed, and to complete the return the Response Form. Instructions in the letters dated 02/12/2018 included to identify any affected devices on hand, complete and return the Urgent Medical Device Recall Response Form, and arrange for repair of the affected as per the location of the consignee in Canada or the USA. If the consignee is located in the USA, the three options include to return to Smiths Medical for repair, arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair, or arrange for onsite repair by Smiths Medical if there are more than 10 pumps onsite. If the consignee is located in Canada, the two options include to return to Smiths Medical for repair or arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair. Consignees not located in the USA or Canada were instructed to contact their Smiths Medical Representative to discuss repair options. For further questions, please send inquiries to SmithsMedical3033@stericycle.com.
August 2025
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
The belt may fail at lower loads than the labeled 600lbs.
The recalling firm sent recall notification via email beginning 09/23/2021. The scope of the recall includes all product (Items 80805, 80806, and 80807) shipped between May 17, 2021 and August 11, 2021. Customers are asked to immediately check stock and quarantine any impacted product. Impacted product is not to be used. Recalled devices must be returned to the recalling firm and will be replaced. A Verification Form should be completed and returned via email to recall@kinsmanenterprises.com. Distributors must promptly notify any potentially impacted customers to which they have further distributed product.
NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MA
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
The recalling firm issued letters dated and mailed on 8/6/2021 notifying consignees of the issue and requesting they immediately check their stock for the affected product and destroy it.
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
Cardinal Health notified customers on about 10/31/2018 via "URGENT: PRODUCT CORRECTION NOTICE." Customers were instructed to examine inventory for affected products, affix the provided warning label on the principal display panel on the affected dispenser packs, notify internal parties and/or customers if the product was further distributed of the recall, and complete and return the provided Acknowledgement Form. If the wallets containing the gloves are removed from the dispenser packs, customers were also instructed to provide a warning label to accompany the affected product inform users of the correct breakthrough times. If customers need additional labels, they were instructed to contact 800-292-9332 or gmb-fieldcorrectiveaction@cardinalhealth.com for assistance. For further questions regarding the Product Correction Notice, please reference the following Customer Service telephone numbers: Hospital (800-964-5227), Federal Government (800-444-1166), Distributor (800-635-6021), All other customers (888-444-5440).
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Cardinal Health issued a letter titled, "Urgent Medical Device Recall", to customers on 06/04/2020. The letter advises customers of a voluntarily recalling associated with lots of Cardinal Health NPWT 300cc Canister with gel and Cardinal Health NPWT 300cc Canister with gel Occlusion Detection. The recall is being conducted due to Canisters potentially containing an oversized O-ring. The canisters with the oversized O-ring cannot be installed into the mating connector on the device causing the device to be unusable. According to the letter, customers should check all storage and usage locations to confirm whether they have any units of the affected product, quarantine all on-hand product and return the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email at GMB-FieldCorrectiveAction@cardinalhealth.com. The returned form should indicate the product code, lot and quantity of product quarantined or discarded. Response is needed whether or not customers have affected product. Customers should notify any customers to whom they may have distributed, or forward the product affected by the recall and should include a copy of the recall notification letter. The firm customer service is available Monday to Friday between 8:00am - 5:00pm Eastern Time. The firm contact information is listed as: Hospital: 800-964-5227, Federal Government: 800-444-1166, Distributor: 800-635-6021, All other Customers: 888-444-5440.
July 2025
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.
Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)
On 10/06/2020, the firm sent a letter to its consignees with the following instructions. Arjo has become aware that there is a likelihood that a sling clip may break (Image 2) when used with the models of spreader bars referenced above that are out of their lifespan (see note 1 below). The continued use of the obsoleted DPS can lead to complete clip breakage and subsequently to its detachment from the DPS attachment point. As a consequence, the resident may fall off and potentially sustain serious injuries as a consequence. Arjo is taking this matter very seriously and recommends replacement of the obsoleted DPS on ceiling lift or floor lift systems. Note 1: The probability of the event may increase if the DPS is used with a Clip Sling that has exceeded its expected lifespan of 2 years or more than 1.5 years for Passive Clip Slings models MAA2080M, MAA2050M, MAA2040M, MAA2070M and MLAAS2000. Next Steps 1. Verify whether you possess DPS within the range of this Notice and ensure that all caregivers and users of Arjo ceiling lift or floor lifts are made aware of this Field Safety Notice (FSN). 2. Complete and sign the enclosed Customer Response Form and return this document to your local Arjo office. Contact your local Arjo office to take the appropriate decision regarding your obsolete device(s) and select the best solution for your needs. NOTE: Until you find with our Arjo representative the most appropriate solution for your patient transfer needs, the device may stay in use strictly if those two conditions are fulfilled; A. Before each patient transfer, ensure to follow the recommendation of the Sling Instruction for Use and check all parts of the sling are free of any damage B. Ensure the sling used is within its intended lifetime (2 years or 1.5 years for Passive Clip Slings models MAA2080M, MAA2050M, MAA2040M, MAA2070M and MLAAS2000). In addition, if the label of the sling is faded, unreadable or damaged, ensure sling disposal as recomme
June 2025
RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 m
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.
The firm initiated the recall by letter on 05/29/2020. The customer letter requested the following actions: "1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Recall Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com or hand it to your sales representative. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products." The distributor letter requested the following actions: "1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have c
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
The firm initiated the recall by letter on 04/01/2019. The letter stated reason for the recall and requested the return of the recalled units. Distributors were directed to collect the recalled units from their customers, consolidate them, and complete and return the acknowledgement form. The recalled units will be returned.
May 2025
MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
The firm received a complaint that the connector detached from the feeding tube.
The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit.
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
On May 21, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all of their consignees which advised them of the problem and provided them with instructions for preforming additional testing. US customers were sent this letter and an attached Customer Reply Immediate Action Required form vis FedEx priority overnight express. Abbott service personnel will follow-up to install new software.
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
A packaging defect may compromise the sterile barrier.
Notification to the impacted consignee was made by letter on 03/01/2023. Consignee(s) are to examine inventory and quarantine any affected product. Notification of the recall must be forwarded to any other impacted entities. Consignee(s) are to complete and return the Acknowledgement and Receipt form to the recalling firm.
April 2025
FlipCutter III Drill
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
Consignees are instructed to return the affected devices which will be replaced.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
The firm,Smiths Medical, sent an, "Urgent Medical Device Recall" Amendment Notice (amending the original August 2017) concerning invalid syringe size alarms on certain Medfusion Syringe Pump Model Series 3500 and 4000. The letter described the product, problem, actions to be to taken, and updated changes, as follows: 1. Locate the affected Medfusion Syringe Pump(s) by referring to the list of affected devices on the attached Urgent Medical Device Recall Notice Response Form. This form provides the specific serial number(s) your organization purchased. Each pump has a unique serial number which can be found on the label located on the bottom of the pump. If you have ten (10) or more affected pumps in your possession, please select one of the following repair options: a. Repair at your Facility: Contact Smiths Medical to schedule a technician to visit your facility and complete the necessary repairs onsite. b. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. c. NEW OPTION - Biomedical Department self-repair at your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. If you have nine (9) or fewer affected pumps in your possession: a. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Customer Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. b. NEW OPTION - Biomedical Department Self-Repair at Your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. To initi
March 2025
Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
On 07/12/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification informing customers that if the seating system is not adequately attached to the stroller base, the seating system may slide off the base and fall to the ground potentially causing injury a child. The Recalling Firm will be providing a safety tether and are informing/instructing their customers to: This Safety Tether Kit will be provided free of charge to all consumers starting the week of July 12, 2021. The Safety Tether Kit will be accompanied by instructions to guide consumers through installing and using the safety tether. The attached consumer communication template letter provide the consumer with three options until their Safety Tether Kit is received and the safety tether has been installed by them: 1. Choose to stop using the ZIPPIE Voyage early intervention stroller until a Safety Tether Kit has been provided and the safety tether has been installed by the consumer. OR 2. If they can elect to continue to use the early intervention stroller (before receiving their Safety Tether Kit and having installed the safety tether) and they can order their stroller with a transit option, they can use the transit strap to securely attach the stroller seat to the stroller handle. The transit strap may function to prevent the seat, if inadequately attached to the stroller base, from falling to the ground. However, the transit strap is not intended to be a replacement for the Safety Tether Kit that we will be providing. The tether set should be installed and used once it is received. OR 3. Experienced users who do not have the transit option on their stroller and choose to continue to use the stroller (before they receive their Safety Tether Kit and have installed the safety tether), must ensure that the stroller seat is securely attached to the stroller base before every use (following the instructions shown in the Owners Manual]). These steps must be performed each and every time the seat
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F MENISCAL COMP.T6 RM/LM 7MM
Malfunction- loosening of the implant resulting in a potential revision surgery
Aesulap issued An Urgent Medical Device Recall via USPS overnight to consignees on March 19, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. A representative of Aesculap will reach out to you to assist in the return of affected product. 1. Review the univation X Knee System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. 2. Active customers with inventory at their site were previously instructed (December 29, 2020 univation X Knee System Field Safety Notification via certified mail) to hold and do not use this product. We are requesting at this time that the product be returned. 3. Action is required of you to sign and return the provided Acknowledgement Response Form identifying (if applicable) the amount of product to the email address listed below before April 16, 2021. If the acknowledgement form has not been received at this time, another Recall Notification Letter will be sent. (Attachment 1 Medical Device Recall Notification Form). Send To: qa-recalls@aesculapusa.com 4. Identify your current inventory for the affected product. a. If you have identified inventory in your facility, DO NOT DESTROY any affected product. Contact Customer Service (info noted below) for an RGR number and return label to return your affected product. AIS Customer Service Number 1-866-229-3002 SetWorld_orders.BBMUS_Service@aesculapimplants.com b. Once the RGR and return paperwork is provided, return a copy along with your affected product to the address listed below. Aesculap Implant Systems SET WORLD HFPU71821 QC Recalls
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
The firm initiated the recall by email on 11/28/2019. The letter explained the reason for recall and requested the following: "Please take the following actions immediately: 1. Please immediately remove all products with the catalog number in question from your warehouse or from affected trays to prevent further use. 2. A confirmation form is enclosed with this letter; please fill in, sign it and return it to us after receiving this information. If you have no affected products, please fill in the confirmation form anyway and fax it to 0049 (0) 30 750 19 111 or email it to incident@aap.de. 3. Please immediately return any products you still have in stock to us. Please ensure that all users of the affected products within your organization and other persons who are affected receive this information via the Field Safety Notice. If products are passed on to third parties, please also send these third parties a copy of the Field Safety Notice or inform our contact. "
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
The recalling firm issued a letter dated 10/12/2022 to their only consignee via email on 10/12/2022. The letter informed the consignee the kits were incorrectly labeled as reference number 78019, the IV Start Kit, but the case label correctly lists the item as the Port Access Kit. The consignee was requested to review their inventory and segregate and quarantine all affected kits labeled as IV Start Kit, lot #294589. If any of the affected kits were further distributed, the consignee was requested to ensure all end users were appropriately notified of the recall. The consignee was to contact the firm for return of the affected kits. A Field Action Response Form was enclosed for completion and return to the firm via email to indicate they have read and understood the recall instructions, checked their inventory, indicated how much was in inventory, and have notified appropriate staff and customers of the recall.
smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
The incorrect device is contained in the package.
The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.
BASIN SET, MEBS42K, general surgical kit
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
The firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to their consignees by email on 10/12/2022. The notice explained the issue and requested the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. If you received any of the batches listed in this notification letter, please contact Breah.Waldridge@owens-minor.com for a replacement kit."
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Pump not detected as connected to controller due to software issue.
An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact adminsfs@abiomed.com to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to.
Baxter Electrocardiograph, ELI 380 -DCS21
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
The customer was contacted on 31 October 2022 to inform them of the issue and instructed not to install the device for use.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
This is a retrospective report for the March 2021 Technical Bulletin, which described a Product Update; specifically the AIC Version 8.5 Software Update. The software update began rollout on March 4, 2021. According to the firm, Version 8.5 of the software contained bug fixes for the issues seen in version 8.4. The technical bulletin was posted to HeartRecovery.com on March 5, 2021.
Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
Customer complaints were received of power to the unit ceasing and the display going blank.
Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it with another unit and call Teleflex for an immediate replacement. A Recall Acknowledgement Form was attached to be completed, scanned and returned to Teleflex Medical to document receipt of this Notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Horizon Cardiology Hemo
users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology Hemo" (Hemo). The discrepancy may also affect administered medication data in reports generated from Hemo or the Horizon/McKesson Cardiology Physician s Report as well as customers, who have implemented an outbound interface of procedure results.
Change Healthcare notified consignees on about 03/25/2019 via "Urgent Field Safety Notice" letter sent through email. The notification informed consignees that the issue can occur under the following 3 circumstances: 1. When a user intentionally updates the Physician Report, overriding procedure medication derived from the Hemo report, or 2. When a user intentionally updates the medication information charted for Pre- or Intra- procedure stage, from the Intra- or Post-procedure stage (respectively), or 3. Due to an unexpected system error. Instructions included that prior to closing a Hemo case, ensure the list of administered medication information is correct on the Vitals and Meds, Procedure Notes, and Patient Common Data screens, and when opening, finalizing or closing the Physician Report, review the procedure medications to ensure that all medication information is correct. Customers were requested to immediately contact Change Healthcare to acknowledge they have read and understand the Urgent Field Safety Notice and to arrange for installation of the software update/upgrade. They were also requested to ensure distribution of the Urgent Field Safety Notice to all personnel within your organization who should be aware of the recall or to other affiliated parties that may be affected by the Urgent Field Safety Notice. Customer Support contacts are as follows: 1. US/Canada: 1-877-654-4366; 2. UK / Ireland: +44 (0) 208 9527399; 3. Australia: 1800 625 435; 4. Israel: +972 52 433 3366
February 2025
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
Important User Notice 382-03-MON-003 was sent to customers on August 18, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The letter also states that the problem will be in a future Monaco release. The customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta as soon as possible but no longer than 30 days from receipt. Questions can be directed to the local Elekta office.
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing.
On November 18, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. Customers were informed that a service representative will contact their facility to schedule a time to replace the batteries in the affected devices. The customer does not need to take additional action while waiting for the battery preplacement. If you have any questions or concerns regarding this update, please contact shirleytechnicalsupport@stryker.com or call Stryker Technical Support at 978 386 9619.
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
On February 4, 2022, Stryker issued an "Urgent: Medical Device Recall notification" to all affected customers. In addition to informing consignees about the recalled product, the firm ask customers to take the following actions: 1.) Please check your inventory for the devices from the affected lot and remove them from their point of use. 2.) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker s Sustainability Solutions Sales Representative c. Fax: 480-763-5345 This form must be completed and returned to Stryker even if no affected product is found. 3.) Maintain awareness of this communication internally until all required actions have been completed within your facility. If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to SSSPFA@stryker.com, to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345. Alternatively, provide contact details so Stryker can inform the recipients appropriately. If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned prior to May 1st, 2022. 4.) Adverse reactions or quality problems experienced with the use of this product should be reported to: " Stryker s Sustainability Solutions Complaint Hotline: +1-888-763-8803 " http://www.stryker.com/productexperience " The FDA s MedWatch Adverse Event Reporting program either online, by
Turbett Surgical Container, TS1500
Devices were subject to unapproved rework processes.
The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load. The firm asks customers to immediately discontinue use of the device and complete the provided Return Response Form to Quality@Turbettsurgical.com. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device. Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM.
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Owens & Minor/Medical Action INDUSTRIES, INC. issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its sole consignee on 09/23/2022 by email. The notices explained the issue and requested they take the following actions: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user information to quality@owens-minor.com. Any adverse events associated with the use of the affected products should be reported to Quality@owens-minor.com. The FDA requires that we account for all affected products. Therefore, please complete the attached Response Form and return to Quality@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please send an email to marlene.jones@owens-minor.com."
Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
Scissors contained debris.
The recalling firm issued letters dated 10/12/2022 via email on 10/12/2022. The letter identified the affected product, the reason for recall, and requested the consignee review their inventory and segregate and quarantine all affected product. If any of the product is found, the consignee is to discard it. If the product was further distributed, the consignee is to ensure all end users are appropriately notified of the field correction. A Field Action response Form was to be completed and returned via email as soon as possible to indicate they have read and understand the recall instructions, checked their stock and reported the quantity of product on hand, and notified their appropriate staff of any customers of the notification.
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay
Potential performance issues in the Alinity-ci software version 2.5.1
On March 7, 2019 Abbott issued the attached Product Correction letters to all installed Alinity ci series instrument customers: 1. Softwarerelated actions: Your Abbott representative will schedule a mandatory upgrade of your Alinity ciseries to software version 2.6.0 to resolve each of these issues. Refer to Appendix A for necessary actions required until software version 2.6.0 can be installed. Software version 2.6.0 also provides enhancements and additional changes to increase the usability of your system. If you require additional information, please contact Abbott Customer Service. 2. The Alinity ciseries Operations Manual distributed with software version 2.6.0 requires supplemental instructions for the following message: Message code 3696 The sample probe is not washed after aspirating a whole blood or red blood cell sample. If message code 3696 occurs, perform the following: a. Perform Asneeded Maintenance procedure 5906 Clean Sample and Reagent Probes (cseries) to clean the sample probe unless one of the following actions occurred before the initiation of assay processing: " The sample probe was replaced. " Daily maintenance procedure 5501 Daily Maintenance (cseries) was performed. b. Additional messages that are associated with this message can be used to determine the appropriate corrective action. Perform View additional messages that are associated with a message in the Alinity ciseries Operations Manual. 3. Bulk Solution Level Sensor related actions (refer to Appendix B for additional information): a. If LN 04S6801 Level Sensor, Bulk Solution is installed in the Alinity i Trigger or PreTrigger bulk solution reservoirs, Abbott recommends these sensors be replaced with a Level Sensor, Bulk Solution, LN 04S6802 before further test processing is performed. b. Abbott recommends all LN 04S6801 Level Sensor, Bulk Solution installed in the following bulk solution reservoirs be replaced with a Level Sensor, Bulk Solution, LN 04
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.
On October 14, 2021 BioCheck issued a "Medical Device Recall Notification" to affected customers. In addition to informing consignees about the recall, BioCheck asked consignees to take the following actions: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify those customers and notify them at once of this product recall. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify appropriate regulatory bodies, if required. 4) Disposal of all affected lots should be in accordance with applicable national, state, and local laws and regulations. 5) Complete and return the enclosed Return Response Form by October 29, 2021 to BioCheck, Inc,, 425 Eccles Avenue, South San Francisco, CA 94080 or email to: jsaito@biocheckinc.com as is required to meet subsequent FDA Status Reporting requirements. CUSTOMER CREDIT 8. Upon receipt of completed Return Response Form, customer's account will be credited for the identified products that are disposed of. If you have any questions, contact Director QA/RA at (650) 573-1968 or email: jsaito@biocheckinc.com.
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Siemens issued Urgent Medical Device Correction, CC 19-07.A.US to customers on July 22, 2019 to be delivered to customers on July 23, 2019. After release of the letter (CC 19-07.A.US), we identified a typographical error in Table 1, specifically the Reference kit SMN (19331250). Version B (CC 19-07-B.US) is being created with the corrected SMN Number (10331250) and distributed to the reference accounts that order SMN (Quest Diagnostics). Urgent Field Safety Notice, CC 19-07.A.OUS was sent out to the country organizations on July 19, 2019 for distribution to customers outside the United States. The customer distribution included all customers that have received both ADVIA Centaur Folate and ADVIA Centaur Homocysteine over the past year. The letters inform customers the potential for the ADVIA Centaur Homocysteine assay to cause elevated Folate results when an ADVIA Centaur Folate test immediately follows an ADVIA Centaur Homocysteine test. The communications provide recommendations to run the assays on different ADVIA Centaur systems or on other Siemens Healthcare systems or to test all Homocysteine samples together followed by the Daily Cleaning Procedure prior to testing the Folate assay to mitigate the interference. Field Correction Effectiveness Check form provided. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative. Update: 11/30/20 Siemens issued Follow Up Customer Notification CC 19-07.C.US and or CC 19-07.B.OUS, dated Dec.1, 2020 via overnight to US customers on December 1st, 2020 and Siemens EU Authorized Representatives issued the letter to OUS countries on December 1st, 2020, stating:Siemens has implemented a new wash mitigation into ADVIA Centaur XPT Folate (FOL) Test Definition (TDef) Version 2.1 and ADVIA Centaur XPT Homocysteine (HCY) TDef Version 1.5 for use on the ADVIA Centaur XPT system and TDef Version EL/EM on the ADVIA Centaur XP system. Actions to be Taken by the Custome
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inappropriate intervention for myocardial infarction
****Recall Expanded 9-21-22*** US Customers were sent Urgent Medical Device Correction (DC-22-2.B.US) on 09/21/2022 and an Urgent Field Safety Notice UFSN DC-22-02.B.OUS) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 09/26/2022. Letter informs them to use serum patient samples only when utilizing lot BA3088. Laboratories unable to use serum patient samples for testing are to request a no charge replacement for their impacted reagent. Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 05/18/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites for distribution and regional reporting to their local competent authorities beginning on 05/18/2022. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Siemens recommends using serum patient samples only when using the lots listed in Table 1. If your laboratory is not able to use serum samples, please discard the reagent and complete the attached Product Replacement form for a no-charge replacement product. Review your inventory to determine possible replacement needs and to provide information to Siemens for reporting to the Authorities. Complete and return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
bioMerieux in the U.S. issued an Urgent Field Safety Notice dated November 2021 on 11/9/2021 via email for delivery to the Lab Director or Lab Manager. The notice described the issue, impact to the customer, and listed the required customer actions: Distribute the information to all appropriate personnel in their laboratory and forward the information to all parties that may use the product, including others to whom the product may have been transferred. The customer is informed they can continue to use RAPID 20 E, however, they must refer to the following Reading Table or to the corrected RAPID 20 E package insert version "G1" available on Resource Center when reading the CIT test result. For tests previously performed using RAPID 20 E, the customer is strongly recommended that they identify any possible misidentifications to analyze the related risks and to determine appropriate actions, if relevant. An Acknowledgement Form was enclosed to confirm receipt of the notice.
Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.
Labeling error
Consignees were notified of the recall by letter on 1/13/2017. The letter requested that they immediately discontinue use and quarantine the recalled product. Distributors were requested to conduct a sub-recall. The letter included a reply form which was to be returned to Teleflex.
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer. The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to: - Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927 - Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.
Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
The bracket torque was mislabeled on the packaging.
The firm, Ormco, sent "URGENT: MEDICAL DEVICE CORRECTION" letters dated 1/6/2020 via USPS on 1/14/2020 to consignees explaining the brackets were mislabeled and the risk associated with using the incorrect bracket. The consignees were requested to call Ormco customer service at 1-800-854-1741 or email: ormcocustcare@kavokerr.com to log any complaints related to this issue; assess your patients; over-label the affected product in inventory using the enclosed corrected label and complete the enclosed acknowledgement form and email the form to ormcocustcare@kavokerr.com within 10 business days. If you have any questions or require additional information, please contact our customer care department at 800-854-1741, between the hours of 7am to 5pm (PST) or send an email to ormcocustcare@kavokerr.com.
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
In February 2021, Siemens will issue an Urgent Medical Device Correction notice to customers via letter stating that Siemens Healthcare Diagnostics Inc. has confirmed that the ADVIA Centaur HSV2 assay does not meet the 60 day onboard stability or the 28 day calibration frequency (interval) as stated in the ADVIA Centaur XP/XPT Herpes-2 IgG (HSV2).
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced.
Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
The firm, Aesculap Inc., issued "URGENT MEDICAL DEVICE CORRECTION" letter dated July 14, 2022. Letter states reason for recall, health risk and action to take: Address the application error concerns, the product instructions for use (IFU) have been updated and a new software version for the Aeos Robotic Digital Microscope (version 2.8.1.115) has been released. All customers are being provided the updated IFU and software. Refer to Actions Required by Aesculap Inc. Customer/User below. 1. Review the Device Correction Notification in its entirety and notify users and other relevant personnel within your organization. 2. Download the updated product IFU and ensure all users are aware of the updates. To obtain the updated IFU, please perform the following steps: a. Using your organizations approved web browser (e.g. Google Chrome, Microsoft Edge, etc.), enter the URL: https://www.aesculapusaifus.com. b. In the search field enter the Item Number: PV010 and press Search c. Click on the file AEOS Digital Microscope IFU (TA015615). Note: You will need a PDF viewer such as Adobe Acrobat to view the file. d. Print or distribute the IFU to relevant personnel. Maintain a copy in close proximity to the device for easy reference by the users. 3. Complete the Product Correction Acknowledgement form. If you have no inventory remaining, enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to our Quality Assurance department by e-mailing to qa-recalls@aesculapusa.com, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement form an Aesculap representative will contact you to arrange for qualified Aesculap personnel to update the software on your device. Report any concerns or issues to our Postmarket Surveillance team by contacting ProductQualityExcellence@bbraunusa.com or by calling 1-833-425-1464.