2022 Product Recalls
0 recalls issued in 2022.
Loose Brake Pad Retaining Clip May Damage Tire
A retaining clip or bracket that detaches can damage the brake pad, reducing brake performance, damage a tire valve, causing a flat tire, or become a road hazard, increasing the risk of a crash.
All affected VanTraxx assemblies have been inspected and repaired as necessary and therefore no owner notification letters will be sent. The affected vehicle manufacturer was notified on September 23, 2022. Owners may contact Hendrickson customer service at 1-630-773-911.
Kickstand May Not Retract Properly/FMVSS 123
A kickstand that does not properly retract can increase the risk of a crash.
Dealers will replace the kickstand, free of charge. Owner notification letters were mailed February 17, 2023. Owners may contact Indian customer service at 1-877-204-3697. Indian's number for this recall is I-23-01.
12-Volt Battery Cable May Short Circuit
A short circuit may cause a loss of drive power, increasing the risk of a crash. A short circuit also increases the risk of a vehicle fire.
Owners are advised to park outside and away from structures until the remedy has been completed. Dealers will inspect the 12-Volt battery charging cable and repair or replace it, as necessary, free of charge. Owner notification letters are expected to be mailed February 27, 2023. Owners may contact Volkswagen's customer service at 1-800-893-5298. Volkswagen's number for this recall is 97HA.
DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes GMBH is reporting Recall of SYNMESH CAGE SYSTEM Japan-Specific Country Label Issue . The Japan affiliate will be administering the recall per their local regulations, the week of September 21, 2020. Affiliate will notify Japanese sales representatives. Japanese sales representatives will hand-deliver notices to affected hospitals / surgeons. The Japan affiliate is responsible for managing the rework process. Returned devices will be reworked with correct Japan-specific labels and revised lots
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.
On 03/25/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via postal mail or email to customers informing them that Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results. In a worst-case scenario, unvalidated or incorrectly validated rules may lead to the generation of erroneous test results that may be reported out of the laboratory. For customers using versions 1.5, 1.6, 1.7, 1.8 or 1.9 are instructed: 1. Validate the rules that were unvalidated or incorrectly validated, according to laboratory procedures 2. All rules set up in the future must be validated, according to laboratory procedures The Recalling Firm strongly encourages the use of the testing instructions provided with this notification, "REMISOL Avanced v1.5 through v1.9 Rule Validation Procedure". The Recalling Firm is currently updating the Instructions For Use for the affected versions and is targeting May 2021 for availability. Customer are also instructed to: -Share this information with their laboratory staff and to retain this information as part of their laboratory Quality System documentation. -If customers are a centralized license holder, they are asked to provide the other affected laboratories of their organization or association with a copy of the notification letter. -Within 10 days of receiving this customer notification, customers are asked to communicate with the Recalling Firm either: 1) Electronically, if they received this communication via email, or 2) Manually, complete and return the enclosed Response Form. For further questions, contact the Recalling Firm via -Website http://www.beckmancoulter.com or -By phone - contact their local Beckman Coulter representative.
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.
Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
Getinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.
Child Seat May Be Improperly Installed/FMVSS 213
The child seat may be improperly installed, increasing the risk of injury in a crash.
Joybuy Express will provide a refund to purchasers. Owner notification letters were mailed February 21, 2023. Owners may contact Joybuy Express' customer service at 1-302-426-4543 or overseas-service@jd.com. This recall expands and replaces NHTSA recall number 22C-007.
ZLINE 30-inch and 36-inch RG gas ranges Recalled for Poisoning Hazard
The oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning.
Consumers should immediately stop using the oven compartment of the recalled ranges until a free repair is available. Consumers may continue to use the range tops which are unaffected by the issue. Contact ZLINE, who is working to develop repairs for all affected units.
Body Glove Tandem Inflatable Stand Up Paddle Board, ULI Recalled for Drowning Hazard
The glue on the inflatable paddle boards can separate at the seams and the paddle boards can deflate unexpectedly, posing a drowning hazard.
Consumers should immediately stop using the recalled boards and return them to Costco for a full refund or contact Surf 9 for instructions on how to receive a refund. Costco is contacting all known purchasers directly.
Yamaha Viking Off-Road Side-by-Side vehicles Recalled for Crash Hazard
Improper installation of the retaining bolts could result in the parking brake mechanism failing to hold the vehicle when parked allowing the vehicle to move unintentionally, posing crash and injury hazards.
Consumers should immediately stop using the recalled vehicles and contact Yamaha Motor Corporation U.S.A. for a free inspection and repair. Yamaha is contacting all registered owners directly.
LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
On 04/01/2021, LeMaitre issued an Urgent Medical Device Removal notice via letter informing customers that particulate contamination has been detected from the packaging foam with these devices.
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans
Siemens issued notification Urgent Medical Device Correction letter on 7/25/19 issued via electronic mail to consignees or by USPS certified mail if a consignee email address was not available. Letter states problem, health risk, action to take: The remote software update installation process will require approximately 30 minutes for completion. The process is completely automatic; make sure the system and power are stable before and during the process and do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in use or when the necessary time for the update to be completed can be scheduled. If your system is connected to Siemens Remote Connection, this update will be performed remotely. Following the corrective action, the cause will be eliminated and a recurrence of the identified issues is prevented. If you have any questions, please contact our service organization at 1-800-888-7436.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Presence of foreign substance
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
Failed Impurities/Degradation Specifications
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
22 oz Blonde; 20 oz Blonde EZ; 24 oz Blonde EZ frozen pizza dough manufactured by It'll Be Pizza
Product may be contaminated with foreign object (debris from packaging).
Red Button Vintage Creamery French Silk Pie, Net Wt. 31.88 oz. (904g), in a clear plastic dome and black plastic base, UPC 0 41172 81290 9, Distributed By: Associated Food Stores, Salt Lake City, Utah 84119 RMYA0421" printed on sleeve. Keep refrigerated.
Pies labeled as Red Button French Silk may contain Turtle Cream Pies containing almonds which are not declared on the French Silk label.
EGA 22 oz Pizza Dough Ball, 20 ct/ case; frozen pizza dough
Product may be contaminated with foreign object (debris from packaging).
Gamesa Arcoiris Marshmallow Cookies, Naturally and Artificially Flavored 15.5 Oz, 6 Count UPC 6 86700 10132 4
Potential to contain Salmonella