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.
AquaStar is recalling 5,400 cases of Kroger Raw Colossal EZ Peel Shrimp because the shrimp may be contaminated with Cesium-137.
AquaStar is recalling 9,900 cases of Best Yet Frozen Raw EZ-Peel White Shrimp across multiple counts because the shrimp may be contaminated with Cesium-137.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.
AquaStar is recalling 3,600 cases of Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp because the shrimp may be contaminated with Cesium-137.
AquaStar is recalling 7,200 cases of AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, sold at WinCo, because the shrimp may be contaminated with Cesium-137.
Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.
B-K Medical is recalling 4,426 1202 Flex Focus ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
Quality Poultry & Seafood is recalling 342 cases of Specialty Stuft Meats Crawfish Stuft Potato over undeclared Yellow 5 and Yellow 6 colour additives.
B-K Medical is recalling 124 bk3500 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 567 Ultrasound System 2300 bkActiv units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 1,697 Ultrasound System 1300 bkSpecto units because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 895 bk5000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
B-K Medical is recalling 496 bk3000 ultrasound systems because the user guide and service manual do not adequately state battery replacement intervals, end-of-life handling or safety precautions.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T1 because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2 because the certification statement required under the radiological health regulations may have been omitted.
OSSTEM Implant is correcting labeling for its Dental X-Ray System T2Plus because the certification statement required under the radiological health regulations may have been omitted.
IMRIS is recalling the IMRIS iMRI 3T V Operating Suite because an ice blockage in the Siemens 3 Tesla magnet's venting system could rupture the helium containment system during a quench. The FDA classified it Class I.
IMRIS is recalling the Neuro III-SV iMRI and iMRX systems because an ice blockage in the Siemens 3 Tesla Verio magnet's venting system could rupture the helium containment system during a quench.
Weaver Nut Company is recalling 849 cases of semi-sweet chocolate nonpareils with Christmas seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.
Weaver Nut Company is recalling 1,760 cases of semi-sweet chocolate nonpareils with white seeds over an undeclared milk allergen. The FDA has classified the recall as Class I.
IMRIS is recalling the InVision 3T Operating Suite because an ice blockage in the Siemens 3 Tesla Vida magnet's venting system could rupture the helium containment system during a quench.
IMRIS is recalling the IMRIS iMRI 3T S Operating Suite because an ice blockage in the Siemens 3 Tesla Skyra magnet's venting system could rupture the helium containment system during a quench.
Dexcom is recalling version 1.15.0 of the G6 and G6 Pro Android CGM app because a software defect can terminate the app, stopping glucose values, alarms and alerts. The FDA classified it Class I.
Doan's Dessert And Coffee is recalling its 4 lb Carrot Bundt Cake over an undeclared wheat allergen in ready-to-eat frozen cakes. The FDA has classified the recall as Class I.
Tai Foong USA is recalling 1,261 cases of Fusia Asian Inspirations Veggie Spring Rolls over undeclared shrimp. The FDA has classified the recall as Class I.