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.
Covidien LP recalls VersaOne Reusable Positioning Cannula due to manufacturing defect that may leave a metal burr inside the device. No injuries reported.
Baxter Healthcare Corporation is recalling 9,788 bags of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to potential leaks in the Luer component. The recall affects Lot Y405201 distributed nationwide in the United States.
ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.
ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.
Northwind Pharmaceuticals is recalling 33 bottles of Doxazosin 4mg tablets due to manufacturing quality control deviations. No illnesses or injuries have been reported.
Siemens recalls the ARTIS one angiography system due to a hybrid cable display issue that may prevent image function on examination room monitors. Four US units are affected.
Creekside Mallow Chocolate Chip Mint Marshmallows are recalled due to butterfat in the chocolate chips not being accompanied by a milk declaration in the Contains statement. The product affects 2,800 packages distributed in Washington and poses a risk to consumers with milk allergies.
Wismettac Asian Foods recalls Shirakiku Brand Japanese Style Noodle Sanuki Udon due to undeclared fish allergen. The product was distributed in California, Colorado, Georgia, and Arizona.
The HAMILTON-C6 ventilator (103 units) has a software error that disables patient input monitoring when switching to adaptive ventilation modes with a connected controller or humidifier. The device will alarm but cannot respond to patient inputs.
Baxter Healthcare is recalling Dianeal Low Calcium peritoneal dialysis solution nationwide due to potential leaks from the container that could compromise sterility. Affected patients should contact their healthcare provider.
Northwind Pharmaceuticals is voluntarily recalling Glimepiride 2mg tablets distributed nationwide due to Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
DuPont Nutrition USA is recalling Avicel DG, a pharmaceutical ingredient, due to failed quality specifications. The product did not meet conductivity standards during manufacturing testing.
Northwind Pharmaceuticals is recalling Buspirone Hydrochloride 7.5 mg tablets due to manufacturing process deviations. The FDA Class II recall affects bottles distributed nationwide.
Methapharm Inc is recalling Pantoprazole Sodium 40 mg injection vials due to a manufacturing procedure deviation. Affected products were inadvertently placed into distribution without proper compliance with approved procedures.
DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.
SCA Pharmaceuticals is recalling Oxytocin 30 units in 0.9% Sodium Chloride solution (73,312 containers) nationwide due to subpotency—product contains insufficient active ingredient.
Wellness BioSciences is recalling its CBD Metered Dose Inhaler nationwide because it was marketed without an approved NDA/ANDA.
DuPont Nutrition USA is recalling specific batches of Avicel PH-101 NF microcrystalline cellulose due to failed conductivity specifications. The pharmaceutical excipient was distributed in bulk to manufacturers in the USA and multiple international locations.
Aesculap Implant Systems recalls Caspar Cervical Retractor (CCR) Basket lids with incorrect GTIN labeling. The product bears GTIN #04046955299592 instead of the correct #04046955299607.
Northwind Pharmaceuticals recalls specific lots of Glimepiride 4mg tablets due to manufacturing practice deviations. Affected tablets were distributed nationwide.
Northwind Pharmaceuticals voluntarily recalls Tadalafil 20 mg tablets nationwide due to manufacturing practice deviations. No illnesses have been reported.
Datascope Corp. is recalling 54 units of the Cardiosave Hybrid Intra-Aortic Balloon Pump distributed to Brazil. The Type J power cord plug is incompatible with Brazilian Type N electrical receptacles.
Northwind Pharmaceuticals is recalling 99 bottles of Atorvastatin Calcium 10 mg tablets nationally due to manufacturing process deviations identified in March 2023.
DuPont Nutrition is recalling Avicel PH-102 microcrystalline cellulose due to conductivity specification failures in 14 batches distributed across the USA and internationally.
North American Food Dist. Co., Inc. is recalling Kagome Chuno Sauce 16.9 fl. oz bottles (UPC 4901306097519) due to undeclared soy. Approximately 125 bottles were distributed in CA, CO, and NV.