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.
Otsuka ICU Medical is recalling 21,696 containers of Potassium Chloride Injection 20 mEq in 50 mL because the overwrap may state 10 mEq. The FDA classified it Class I.
Twin Sisters Creamery is recalling 237.34 pounds of raw milk Mustard Seed cheese due to E. coli O103:H2 and E. coli O74:H25. The FDA classified it Class I.
Peterson Company is recalling 288 pieces of Twin Sisters Creamery Whatcom Blue cheese due to E. coli O103:H2. The FDA has classified the recall as Class I.
Twin Sisters Creamery is recalling 115.46 pounds of raw milk Peppercorn cheese due to E. coli O26:H11. The FDA has classified the recall as Class I.
Peterson Company is recalling 288 pieces of Twin Sisters Creamery Farmhouse White cheese due to E. coli O103:H2. The FDA has classified the recall as Class I.
New Hoque and Sons is recalling five cases of Dry Ghoinnya Fish because un-eviscerated fish may be contaminated with Clostridium botulinum. The FDA classified it Class I.
Plenus Group is recalling 659 cases of Rockport Lobster Bisque because the product contains undeclared shrimp. The FDA has classified the recall as Class I.
CareFusion is recalling 2,574,396 BD Alaris Infusion Pump Modules 8100 because a dropped or jarred pump can suffer bezel damage causing under-infusion, over-infusion or unregulated flow.
Bulk & Organic is recalling 565 bags of Organic Moringa Powder, 44.1 lbs each, over possible Salmonella Richmond. The FDA has classified the recall as Class I.
Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.
Medline is recalling 28,679 laparotomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.
Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.
Haitai is recalling 69 cases of Cinnamon Powder in 8 oz containers because of elevated levels of lead.
Medline is recalling 301 breast biopsy and mastectomy convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Sterilmed is recalling four reprocessed ACUSON AcuNav diagnostic ultrasound catheters because they were reprocessed beyond validated cycles.
Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.
Greiner Bio-One is recalling 1,980,000 Vacuette 8 ml serum separator tubes because some were manufactured without the gel separator, which could yield erroneous assay results.
Meridian Bioscience is recalling alethia C. difficile nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.
Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.
Meridian Bioscience is recalling Group B Streptococcus nucleic acid amplification test assays because the reaction buffer tube cap may be missing its rubber gasket.
Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.