FDA Device Recalls
Defects in medical devices
Archive by Year
Recent Recalls
GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted.
The firm initiated the recall beginning on 10/25/2022 by telephone and email, following with a "MEDICAL DEVICE RECALL" notice. The notice stated the problem and requested the following: "Greer requests that you immediately discontinue use of the M. faeni Dia-Kit antigen lot(s) and return any remaining stock of the lots in question. Please contact a Greer Customer Service Representative at 1-800-378-3906 between 8 a.m. and 5 p.m. Eastern Time to receive a Returned Goods Authorization number and arrange for return of the product. Your Greer Customer Service Representative will also arrange for replacement of the product."
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
Medline Industries, LP sent a MEDICAL DEVICE RECALL notice to its consignees on 09/08/2022 by US Mail. The notice identified the product, problem, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listedon the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list thequantity of affected product you have in inventory on the form. Even if you do not have anyaffected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-131-FG Recall Code: RXXXXXXX 3.Upon receipt of your submitted response form, return labels and RGA information will beprovided, if applicable. Your account will receive credit when the returned product is received. 4.If you are a distributor, or have resold or transferred this product to another company orindividual, you are required by FDA regulations to notify them of this recall communication.Have the customers return any affected product to you for collection and return to MedlineIndustries, LP. If you have any questions, please contact the Recall Department at 866-359-1704."
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.
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Ulrich notified initially notified customers, via phone call, on 12/20/2019. On about 12/31/2019, customers were also sent an official "URGENT SAFETY INFORMATION: MEDICAL DEVICE CORRECTIONS & REMOVALS" letter. Customers were informed that the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. Instructions included cease use of the affected devices, return them to Ulrich, and complete and return the provided "Product Recall" form. Customers were also instructed to inform all users of the devices within each organization are informed. Questions or concerns can be directed to Mr. Louis Milos, Sr. Manager Business and Quality Systems, at 636-519-0268 ext. 105, l.milos@ulrichmedicalusa.com, Monday through Friday 8:00am to 5:00pm CST.
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.
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.
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
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.
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.