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.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Olympus is recalling its Resection Sheath, 26 Fr, with Deflecting Obturator, model A22042T, used in urologic applications, after complaints that the ceramic tip can break.
Olympus is recalling Resection Sheath models A22014A and A22014T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.
Wizcure Pharmaa is recalling all lots of Vista Tears Polyethylene Glycol 400 and Propylene Glycol eye drops because the products were not manufactured in conformance with current good manufacturing practices.
Medline is recalling Meijer Sterile Saline Wound Wash First Aid Cleansing Spray because the manufacturer may not have made the product to the minimum sterility assurance level required for sterile products.
J2C Hawaii is recalling Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel because the ingredients list declares peanut but the Contains statement does not.
Olympus is recalling its Resection Sheath model A2666T, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the sheath can break.
Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Olympus is recalling its Resection Sheath, 28 Fr, model A22043A, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Olympus Corporation of the Americas is recalling Olympus Cystoscope Outer Sheath (Model WA22810A) because it may be incompatible with GreenLight Laser therapy, potentially damaging the device tip.
Wizcure Pharmaa is recalling all lots of BioGlo Fluorescein Sodium Ophthalmic Strips in 100-strip packs because the products were not manufactured in conformance with current good manufacturing practices.
Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.
Medtronic is recalling one lot of the Octopus Nuvo Tissue Stabilizer after identifying an assembly issue in which the short and long tubes were attached to the wrong ends of the canister.
Olympus is recalling its Sheath, 10 Fr, model A37004A, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip can break.
Olympus is recalling its Resection Sheath, 24 Fr, with Deflecting Obturator, model A22041T, used in urologic applications, after complaints that the ceramic tip of the resection sheath can break.
Slade Gorton & Co. is recalling Wellsley Farms Farm-Raised Atlantic Salmon, 32 oz, because it is contaminated with Listeria monocytogenes.
Medline is recalling Nail Kit convenience kits, model POD14214, because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
Agebox is recalling iKids-Growth (Night Formula) 60-count bottles because the product was marketed without an approved NDA or ANDA and contains undeclared ibutamoren.
Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.
Olympus is recalling its Inner Sheath, model A2660, used for endoscopic diagnosis and treatment in urological applications, after complaints that the ceramic tip of the resection sheath can break.
Wizcure Pharmaa is recalling all lots of Bio Glo Fluorescein Sodium Ophthalmic Strips in 300-strip packs because the products were not manufactured in conformance with current good manufacturing practices.
Medline is recalling five Trunk Kit convenience kits because the manufacturer of the sterile saline wound wash they contain may not have met the required sterility assurance level.
Wizcure Pharmaa is recalling all lots of Vista Meibo Tears Propylene Glycol 0.6% eye drops because the products were not manufactured in conformance with current good manufacturing practices.
Olympus is recalling its Resection Inner Sheath for 26 Fr outer sheath, model A22040A, used in urologic applications, after complaints that the ceramic tip can break.
Encore Medical is recalling Reverse Shoulder Prosthesis humeral socket inserts, catalogue number 509-00-432, because knee and humeral socket implants contain incorrect labeling.