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.
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Medline LABOR TRIAGE KIT convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 960 units affected.
Turkeyfoot Creek Creamery Cacao Brownie Bites Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy and wheat. All expiration dates are affected.
GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.
Medline blood culture convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 15,700 units affected.
Gedney dill pickle products, including Whole Pickles and Mini Munchers Kosher Dill, are being recalled because product slated for disposal due to damage was inadvertently sold. 3,520 cases affected.
Gedney Zinger pickle products are being recalled because product slated for disposal due to product and container damage was inadvertently sold. 3,520 cases are affected.
Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Gedney Ghost Pepper LIL Pickles are being recalled because product slated for disposal due to product and container damage was inadvertently sold. 3,520 cases are affected.
Prolia (denosumab) injection 60 mg/mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 6 pre-filled syringes are affected.
Evenity (romosozumab-aqqg) injection 105 mg/1.17 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 2 pre-filled syringes affected.
The Cone with Male Tubing, Non-Locking, Ellik Evacuator, model 191-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Benlysta (belimumab) for injection 400 mg/20 mL is being recalled because of CGMP deviations involving potential temperature excursions due to transit delays. 3 vials are affected.
The Ellik Evacuator, model 194, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 11 units are affected.
Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.
Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
The Ellik Evacuator Adapter, Locking, model 190-NRS, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 5 units affected.
Sushi Wasabi 5 gram ready to eat mini packs are being recalled because the individual consumer size label does not declare the ingredient Yellow 5. 1,848 cases are affected.
The Glass Body for the 194 Ellik Evacuator, model 190A, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.
A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.
Herbalife Nutrition Relaxation Tea is being recalled because an incorrect ingredient was received from the supplier and used in manufacturing the finished product. 5,888 units are affected.
The Ellik Latex Bulb, model 194-2, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU. 48 units affected.
The Tubing for Male Connector 194, Ellik Evacuator, model 190-4, is being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.