Complete FDA and NHTSA recall records dated in September 2025.
These records include useful source details for the selected month.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
BMW of North America, LLC (BMW) is recalling certain 2019-2021 BMW 330i, 2019-2022 BMW Z4, 2020-2022 BMW 530i, X3, X4, Toyota Supra, 2021-2022 BMW 430i, 430i Convertible, and 2022 BMW 230i…
General Motors, LLC (GM) is recalling certain 2021 Cadillac Escalade, 2021, 2023-2024 Chevrolet Tahoe, and 2022 and 2024 GMC Yukon vehicles equipped with a 6-cylinder diesel engine. The…
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that…
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F…
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that…
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Failure of fusion system instruments in the field.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that…
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to…
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information…
Potential for undetected, deformed a-traumatic tips.
Dipstick strep A test has potential for false positive results.
Measles IgM Test Kit lacks premarket approval or clearance.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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.
