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 all lots of its Inner Sheath 21 Fr. Model A2660T used in urological procedures due to reports of the ceramic tip breaking during use.
Olympus is recalling all lots of its Inner Sheath, Model A2641, used in urological endoscopic procedures, due to complaints that the ceramic tip can break during use.
Medline is recalling 8,773 NAIL KIT (Model DYKM1528) units because the sterile saline wound wash may not have been manufactured to the required sterility assurance level for sterile products.
Olympus is recalling 207 units of its Resection Sheath, Model A22043T, after receiving complaints that the ceramic tip can break during use. The recall affects all lots distributed nationwide.
Wizcure Pharmaa is recalling all lots of Fluorescein Sodium Ophthalmic Strips because the products may not have been manufactured according to current good manufacturing practices, raising concerns about sterility assurance.
Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.
Agebox is recalling 665 bottles of iKids-Growth Day Formula capsules because they contain undeclared ibutamoren, a drug ingredient not approved for marketing in the U.S.
Navitas Organics is recalling organic chia seeds due to potential Salmonella contamination. The recall affects 114,432 units distributed across 26 U.S. states.
Encore Medical, LP is recalling 14 EMPOWR 3D KNEE implants because they contain incorrect labeling. The recall affects US nationwide distribution.
Min Jiang Food Store, trading as Koi Koi Trading, is recalling frozen Fish Ball in 400 g packs because of undeclared wheat and sesame. The FDA has classified this recall as Class I.
Min Jiang Food Store, trading as Koi Koi Trading, is recalling frozen Fish Ball in 200 g packs because of undeclared wheat and sesame. The FDA has classified this recall as Class I.
Prime Food Processing is recalling Dried Croaker Fish, 8 oz, because the fish is uneviscerated. The FDA has classified this recall as Class I, its most serious category.
Medline Industries, LP is recalling Medline Sterile Saline Wound Wash because the product may not meet required sterility assurance levels.
Olympus Corporation of the Americas is recalling Olympus Inner Sheath, Long (Model No. WA22017T) because the ceramic tip may break.
Medline Industries, LP is recalling specific Medline Kits containing Tego Connectors because the silicone seals may dome or tear, potentially causing fluid leakage or blocked paths.
Olympus is recalling 3,484 Resection Sheaths, Model A22041A, after receiving complaints that the ceramic tip can break during urologic procedures. The recall covers all lots distributed nationwide.
Olympus is recalling 899 units of its 8 mm Resection Sheath (Model A42011A) used in gynecological procedures after receiving complaints that the ceramic tip can break during use.
Olympus is recalling 1,676 resection sheaths after complaints of ceramic tips breaking during urologic procedures.
Olympus is recalling its Inner Sheath Model A2642, a medical device used in urological procedures, after receiving complaints that the ceramic tip can break during use.
Vizcure Pharmaa Private Limited is recalling Vista Hypromelose Dry Eye Relief eye drops due to lack of assurance of sterility. The products were not manufactured in conformance with current good manufacturing practices.
MRIMed Inc. is recalling 314 MRI LED Mobile Exam Light Batteries due to battery component overheating while charging, which can cause internal component melting and smoke.
Hitachi is recalling its Proton Beam Therapy system due to a software anomaly in the patient positioning system that may cause positional discrepancies during treatment.
Olympus recalls Model A2666 Resection Sheath for urologic use after receiving complaints of the ceramic tip breaking during procedures.
LEO Pharma is recalling its ADBRY injection drug due to particulate matter (wool fiber) found in one unit, which may affect sterility. The recall covers 11,407 units distributed nationwide.
SB Food LLC is recalling Yoyo Gummy Grape Plus Flavor, 2.8 oz bags, because the products contain an unallowed color, Carmoisine (E122) - Acid Red 14.