305 recalls tagged with “federal law violation”.
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Gina Marie Bakery LLC recalled 172 cases of Toasted Almond & Cherry Biscotti after the FDA flagged undeclared Red 40. The recall is classified as high hazard. Consumers should avoid the product and contact the company for refunds or replacements.
Potential for compromised integrity of the sterile packaging.
Potential contamination with heavy metal (Lead).
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Product may be contaminated with Listeria monocytogenes.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.