Complete FDA and NHTSA recall records dated in November 2023.
These records include useful source details for the selected month.
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Presence of Particulate Matter: Silicone
Ford Motor Company (Ford) is recalling certain 2024 Mustang vehicles. The brake pedal assembly may have been manufactured incorrectly, which can result in a loose brake pedal.
Ford Motor Company (Ford) is recalling certain 2022 F-150 vehicles. The parking lights may flicker when the headlights are activated. As such, these vehicles fail to comply with the…
Chrysler (FCA US, LLC) is recalling certain 2023 Ram 1500 Classic, Ram 3500 Classic, 3500 Cab Chassis, 2023-2024 Ram 2500, 4500/5500 Cab Chassis, and Ram 3500 vehicles. The steering column…
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image…
The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous…
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment.
Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By…
When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be…
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction…
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image…
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image…
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the…
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube…
Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
Sub-ingredients not declared for sunflower butter.
Sub-ingredients not declared for sunflower butter.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
