Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kits (Part Number AMS14994A) due to a potential for backflow of medication from secondary IV containers into primary IV containers. The recall affects 520 units distributed nationwide.
Teva Pharmaceuticals is recalling Claravis (isotretinoin) 10 mg capsules due to failure to meet impurity specifications. The affected lots were distributed nationwide in the USA, Puerto Rico, and the Virgin Islands.
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
Medline Industries is recalling certain Angio Cath Pack kits (Model DYNJ24517D, Lot 25CBA224) because their regulatory 510(k) clearances have been rescinded by the FDA.
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Medline Industries has recalled multiple control syringes, guidewires, and high-pressure tubing models because their FDA 510(k) regulatory clearances have been rescinded. The recall affects 38,230 units distributed nationwide.
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
Premier Dental Products is recalling Monsel's Solution (ferric subsulfate) 8 mL vials because the expiration date on the vial itself is printed with an extra digit (2709114 instead of 270914). The carton expiration date is correct.
Pending LLM rewrite. Source: FDA_FOOD H-0665-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0664-2026.
Pending LLM rewrite. Source: FDA_FOOD H-0681-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0485-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0476-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0462-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0452-2026.
Pending LLM rewrite. Source: FDA_DRUG D-0461-2026.