Omnia Medical TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled recall — FDA Z-2557-2025
Failure of fusion system instruments in the field.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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
Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
Product tested elevated coliform counts during routine testing
Products may be contaminated with Listeria monocytogenes
Potential for spoilage due to yeast contamination.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a…
Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct,…
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
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