689 recalls tagged with “fda regulated”.
B Braun Medical recalled 41,016 IV administration sets on October 29, 2025. The recall addresses the risk of medication backflow into primary IV containers. This issue could lead to significant health risks for patients receiving intravenous therapy.
B Braun Medical recalled 12,320 burette sets on October 29, 2025, due to a risk of medication backflow. This defect can lead to serious health risks for patients. The recall affects devices distributed worldwide, including the U.S., Canada, Germany, Guatemala, and Singapore.
B Braun Medical recalled 2,100 IV administration sets on October 29, 2025. The recall follows reports of backflow of medication from secondary IV containers into primary IV containers. This poses a high risk for patients using the Infusomat Space, Outlook, and Vista pumps.
Illumina recalled 11,916 NextSeq 550Dx reagent kits on October 28, 2025. Flow cell gaskets in these kits may leak during DNA sequencing runs, risking toxic exposure to users. Healthcare providers must stop using these devices immediately and follow recall instructions.
Agebox recalled its iKids-Growth Night Formula due to the presence of undeclared ibutamoren. The recall affects 60-count bottles manufactured exclusively for AGEBOX Inc. Consumers should stop using the product immediately and contact Agebox or their healthcare provider for guidance.
Medline Industries recalled 1.57 million units of Curad Touch-Free and Quick-Strip Bandages on October 27, 2025. The packaging may exhibit open seals, compromising sterility. Consumers should stop use immediately and follow the recall instructions provided by the manufacturer.
Whatcom Blue Sliced Cheese was recalled on October 27, 2025, due to potential E. coli contamination. The recall affects 411 lbs of cheese sold at Whole Foods Market in Washington and Oregon. Consumers should not consume the product and seek a refund or replacement.
Medline Industries recalled 11,291,800 units of Quick Strip Fabric Sterile Adhesive Bandages on October 27, 2025. The recall affects all lots due to potential open seals that compromise sterility. Consumers should stop using these bandages immediately.
EDAN recalled 3,824 Patient Monitors on October 24, 2025. The recall follows an FDA letter regarding cybersecurity vulnerabilities. Affected models include X8, X10, and X12, distributed nationwide and to Mexico.
GE Medical Systems recalled 1,818 Senographe Pristina mammography systems on October 24, 2025. The recall affects systems due to missing or incorrect X-Ray Warning labels. This nonconformance to FDA regulations poses a high hazard risk.
Invagen Pharmaceuticals recalled Lanthanum Carbonate chewable tablets on October 24, 2025, due to stability issues. The tablets failed hardness specifications, posing a high hazard level. Healthcare providers and consumers should stop using the product immediately.
Water Pure recalled 17,612 bottles of My Bladder dietary supplement on October 24, 2025. The product may be contaminated with E. coli O7:K1 and E. coli 1303. Consumers should stop use immediately and seek refunds.
EDAN recalled 13,934 M3 Vital Signs Monitors on October 24, 2025 due to potential cybersecurity issues. The recall affects devices distributed in multiple U.S. states and Mexico. Healthcare professionals must stop using the device immediately and follow manufacturer instructions.
Bristol-Myers Squibb recalled 12,778 vials of Opdualag injection on October 21, 2025. The recall stems from a lack of assurance of sterility. The affected products were distributed nationwide in the United States.
123Herbals LLC recalled SILINTAN 25-pill bottles sold nationwide in the United States after FDA analysis found undeclared meloxicam. An NDA/ANDA violation is cited. Consumers and healthcare providers should stop using this product immediately and contact 123Herbals LLC for guidance.
M.C.I. Foods recalled 330 cases of Cheese and Egg with Green Salsa Breakfast Burritos on October 16, 2025. The cooked egg ingredient tested positive for Listeria Monocytogenes. The product is not for retail sale and was distributed to seven distributors nationwide.
Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.
CA Botana International recalled 470 tubes of Doctor D. Schwab Controlling Cream on October 10, 2025. The recall stems from CGMP deviations that pose a high hazard risk. Consumers should stop using the product and seek guidance from healthcare providers.
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg on October 10, 2025, due to failed stability testing. The recall affects capsules packaged in blister packs and sold nationwide. Consumers must stop using the product immediately and seek guidance from healthcare providers.
STAQ Pharma Inc. recalled Ketamine Hydrochloride 50mg/5 mL syringes on October 9, 2025. The recall affects products with incorrect or missing lot and expiration dates. The FDA classified this recall as Class III due to potential risks to patient safety.