2022 Product Recalls
5,181 recalls issued in 2022.
Showing 61–80 of 5,181 recalls
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.
An urgent medical device recall letter, dated 11/10/2017, was sent to customers informing them that Beckman Coulter was initiating a field action for the iQ200 Series Urine Microscopy Analyzer with Barcode Reader, which may fail to read urine sample dilution barcode labels instead defaulting to no dilution, dilution factor of 1:1. In addition, this product may also fail to read urine sample dilution barcode labels, when the rack is rejected, leading to no results. Customers were informed of the issue, impact, action, and that the resolution was being investigated. Customers were instructed to respond within 10 days: electronically via email or manually by completing and returning the response form accompanying the device recall letter. Customers with questions regarding the notice were instructed to contact the Customer Support Center: electronically at http://www.beckmancoulter.com/customersupport/support or via phone at 1-800-854-3633, in the United States and Canada. Customers with questions located outside the United States and Canada, were instructed to contact local Beckman Coulter representatives.
Sardines in tomato sauce packed in cans labeled in part, "WILD PACIFIC SARDINES RAINCOAST TRADING TM***IN TOMATO SAUCE***NET. 4.2 oz (120 g)***INGREDIENTS: SARDINES, WATER, TOMATO PASTE, SEA SALT. PRODUCT OF MALAYSIA PACKED FOR: RAINCOAST TRADING, NANAIMO, BC CANADA V9R6Z5***8 10757 00917 7***BEST BEFORE 19 JUL 2024***"
Canned sardines in tomato sauce recalled due to high levels of histamine.
High Voltage Battery ECU May Interrupt Power
An interruption of electrical power may result in a sudden loss of drive power, increasing the risk of a crash.
Dealers will update the high voltage battery ECU software, free of charge. Owner notification letters are expected to be mailed February 10, 2023. Owners may contact BMW customer service at 1-800-525-7417.
Upper Steering Shaft Connection May Loosen
A loose steering shaft can cause a loss of steering, increasing the risk of a crash.
Dealers will replace the steering column and shaft components, free of charge. Owner notification letters were mailed on February 1, 2023. Owners may contact New Flyer's customer service at 1-204-224-6706. New Flyer's number for this recall is R22-035.
Driver's Seat Backrest Missing a Bolt
A loose driver's seat backrest may not properly restrain the occupant during a crash, increasing the risk of injury.
Dealers will inspect the driver's seat backrest and if necessary, install an attachment bolt, free of charge. Owner notification letters are expected to be mailed February 17, 2023. Owners may contact BMW customer service at 1-800-525-7417.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
All affected customers were sent a letter on 09/03/2020 stating the following : Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for. An inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as "not in inventory and unavailable for return." Zimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. Product returned from the field will be scrapped.
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
The firm initiated the recall by letter on 12/15/2020. The letter requested the following: "INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS: 1. Locate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice. 2. Determine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession. 3. All affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX. 4. Product credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed. 5. DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately."
Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.
Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Distribution of the "URGENT MEDICAL DEVICE RECALL NOTICE" dated 01/29/2021 during the week of January 18, 2021.
Coolant Leak in EPCU May Cause Loss of Drive Power
Coolant contacting the EPCU circuit board may cause a loss of drive power, increasing the risk of a crash.
Dealers will inspect and replace the EPCU, as necessary, free of charge. Owner notification letters were mailed March 22, 2023. A second notice will be sent once the final remedy is available. Owners may contact Hyundai customer service at 1-855-371-9460. Hyundai's number for this recall is 239.
Mirror May Detach and Become Road Hazard
A molded hood mirror that falls into the roadway can become a road hazard, increasing the risk of a crash.
Dealers will inspect for a wire harness or tether and replace the hood mirror assembly as necessary, free of charge. Owner notification letters are expected to be mailed February 14, 2023. Owners may contact Peterbilt's customer service at 1-940-591-4220. PACCAR's number for this recall is 22PBF.
Suspension Tracking Rod Brackets May Fail
An unstable axle can decrease vehicle stability and control, increasing the risk of a crash.
Dealers will inspect the welds and add an additional bracket between the tracking rod bracket and axle housing, as necessary, free of charge. Owner notification letters are expected to be mailed February 14, 2023. Owners may contact Peterbilt's customer service at 1-940-591-4220. PACCAR's number for this recall is 22PBL.
Center Console May Open in a Crash/FMVSS 201
A center console that opens during a crash can allow unsecured cargo to eject into the cabin, increasing the risk of injury.
Dealers will replace the front center console storage compartment, free of charge. Owner notification letters were mailed February 3, 2023. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2023010008.
Rear Axle Differential Housing May Crack and Break
A loss of rear wheel control and drive power can increase the risk of a crash. In addition, differential oil that leaks onto the road can increase the risk of a crash.
Owners are advised not to drive their vehicles until the vehicle has been remedied. Dealers will inspect and replace the rear axle, as necessary, free of charge. The MBUSA Customer Assistance Center will assist owners to make arrangements with their authorized Mercedes-Benz dealer to have the vehicle towed for inspection. Towing and loaner vehicles or alternate transportation, where available, will be offered at no cost to the customer. Owner notification letters were mailed May 12, 2023. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2023040001.
Loss of Steering Control
A loss of steering control can increase the risk of a crash.
Dealers will replace the steering coupling locking screw, free of charge. Owner notification letters were mailed January 27, 2023. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2022120016.
Insufficiently Attached Dashboard
Improper deployment of an air bag can increase the risk of injury.
Dealers will replace a portion of the dashboard, free of charge. The owner notification letter was mailed January 20, 2023. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2023010001.
High Voltage Battery Packs May Fail
A sudden loss of traction power while driving increases the risk of a crash.
LeM will replace the battery, free of charge. Owner notification letters were mailed February 6, 2023. Owners may contact LeM customer service at 1-970-744-4926 or 1-800-223-0740. LeM's number for this recall is LeM Recall 2022-002.
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
Inability for the user to inject the paste from the syringe into the target location.
On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
On 11/9/2020, Canon issued a "Urgent: Medical Device Correction" letter to all affected customers via facsimile. In addition, to informing consignees about the recall, the firm ask affected consignees to take the following actions: 1. Until corrective action has been taken, in order to avoid the problem, please use the system with setting InstaView OFF according to the last notification (dated June 2020) Subject: Abnormality in Realtime Reconstruction Images. Please see Attachment A. 2. Please share this information with all users and reviewing radiologists as well as the clinical engineering or biomedical group at your facility. 3. If you have any questions, please feel free to contact Terry Schultz Regulatory Affairs Manager at (800) 421-1968 or your local Canon service representative at (800) 521-1968.
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
Tungsten coils of the guidewire included in the introducer kit were detaching.
On 04/26/2020, the recalling firm sent Urgent Medical Device Recall letter by email to the affected customer/hospital/distributor. The letter will identify the product, the problem, and the action to be taken by the recipient (customer).
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
On 07/20/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customer informing them that an issue has been identified in the manufacturing process which might contribute to elevated rates of false negative results while using the BCID Panel. Actions to be taken by customers: 1) Immediately examine their inventory for product identified in this recall, 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Complete the accompanying Field Action Acknowledgment of Receipt Form and confirm the number of pouches scrapped (if any). Return the Acknowledgment of Receipt to the Recalling Firm so that it may acknowledge their receipt of this notification. 4) If they may have further distributed the affected product, identify any recipients and notify them at once of this product recall. For product replacement, as well as any other questions or concerns, contact customer support department at Support@biofiredx.com or via telephone at 1-800-735-6544 and selecting option 5 for Product Technical Support.