Complete FDA and NHTSA recall records dated in 2025, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
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.
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur…
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…
BMW of North America, LLC is recalling certain 2025-2026 X1 and X2, MINI Cooper Convertible, MINI Cooper, Mini Countryman S ALL4, and 2025 MINI Countryman SE ALL4 vehicles. The torsion bar…
Products may be contaminated with Listeria monocytogenes
Products may be contaminated with Listeria monocytogenes
Products may be contaminated with Listeria monocytogenes
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.
