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 122 Airway Mobilescope units nationwide because the endoscope can become lodged in endotracheal tube connectors due to oversized diameter. Healthcare providers should immediately stop using affected devices.
C & S Wholesale Grocers is recalling approximately 29,469 cases of plant-based and tofu products sold at Stop & Shop stores in the NY Metro Region due to improper temperature control during storage and distribution.
Central Admixture Pharmacy Services is recalling 104 neonatal TPN starter bags (Lot 36-260022) due to lack of validation data for sanitization cycles, which could compromise sterility assurance in this IV medication.
Stryker Corporation is recalling the SurgiCount+ Software Application due to potential miscounting of surgical sponges when scanning multiple items from the same package. The software may fail to accurately track RFID-tagged absorbent articles.
The FDA is recalling rocuronium injectable syringes due to unvalidated sterilization processes. The product was distributed nationwide.
Siemens Healthcare Diagnostics has recalled the Atellica CH LDL Cholesterol Direct diagnostic device due to reagent carryover affecting magnesium test accuracy. Approximately 8420 units distributed nationwide and internationally are affected.
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Burning Acre is recalling Gummy Square gummies in .12oz packages due to undeclared soy lecithin, a major allergen. Consumers with soy allergies could experience allergic reactions.
Accuray is recalling upper roller brackets for the Radixact Treatment Delivery System because they may not provide sufficient clearance for service personnel to safely use equipment during maintenance, creating a possible injury risk.
C & S Wholesale Grocers Inc. is recalling Asian food products sold at Stop & Shop stores in the New York Metro Region due to improper temperature storage. Products include noodles, dumplings, egg rolls, and tofu items.
Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
Baxter Healthcare is recalling DIANEAL Low Calcium With Dextrose peritoneal dialysis solution due to potential leaks from the Luer component that could compromise sterility. The FDA classified this as a Class II recall.
Central Admixture Pharmacy Services recalls 297 bags of phenylephrine IV solution due to lack of validated sanitization procedures. The Class II recall affects nationwide distribution.
Siemens Healthcare Diagnostics is recalling 11,824 units of Atellica CH Triglycerides test kits due to reagent carryover from other test parameters that can affect magnesium measurement accuracy. The FDA classified this as a Class II recall.
Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.
Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.
Oculus Pentacam AXL optical devices with insufficient anti-reflective coating may produce incorrect axial length measurements, affecting 364 units distributed nationwide.
Central Admixture Pharmacy Services is recalling 577 bags of heparin IV solution (2500 units/500mL) nationwide due to lack of validation data for sanitization cycles, which could compromise sterility assurance.
Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
The Skytron GS70H Salus Surgical Table may continue moving after the control button is released when operating in Bluetooth mode or when communication is interrupted. The defect could cause unexpected table movement during surgery.
Moore Family Farms Creamery is recalling Cheddar Cheese Curds from Iowa due to potential E. coli and elevated coliform contamination. Consumers should not consume the product.