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.
Todd's Seeds LLC is recalling alfalfa sprouting seeds due to potential contamination with E. coli and Salmonella. The recall is nationwide.
Todd's Seeds LLC is recalling Broccoli & Friends Sprouting Seed Mix because it contains alfalfa seed that may be contaminated with E. coli and/or Salmonella.
Salata Dressings is recalling Jalapeño Avocado Dressing due to potential Salmonella contamination in diced jalapeños. The product was distributed in Georgia, North Carolina, and Texas.
Volcano Corp is recalling 19 Philips IntraSight Plus systems because software may incorrectly associate patient image data with the wrong medical record.
Medline is recalling specific homecare bed hand pendants because the pendant or wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire.
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers due to a risk of blood-to-glycol leaks during cardiopulmonary bypass procedures.
LMSI, LLC is recalling Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil because it contains garlic essential oil, which is not approved for culinary use.
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers because a defect may cause blood to leak into the glycol heat transfer fluid.
Medline Industries is recalling Basic and Medlite Homecare Beds due to a potential fire hazard involving the hand control pendant and wiring.
Draeger is recalling VentStar Resus Neo neonatal breathing circuits due to potential hose cracks that could cause leakage or disconnection.
Aurolab Trust is recalling FOCUS PI eye drops because the agency could not verify the product's sterility. Consumers in Virginia should stop using the product.
Penumbra Inc. is recalling 43 RED 62 Reperfusion Catheters due to manufacturing issues that may cause the catheters to fracture.
Par Health USA is voluntarily recalling 154,210 bottles of Buprenorphine Hydrochloride Injection due to crystallization. The FDA classifies this as a Class II recall.
American Contract Systems Inc. is recalling 1,804 medical kits containing BD CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
Philips is recalling Spectral CT 7500 software due to a tracking crash that may cause patients to receive additional radiation.
SV Labs Toronto Corporation is recalling specific lots of Benzoyl Peroxide Wash, USP, 10% due to microbial contamination. The affected products were distributed only in Illinois.
Heraeus Medical GmbH is recalling PALACOS R+G pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall affects 59,660 units distributed worldwide.
American Contract Systems Inc. is recalling 1,804 medical convenience kits containing potentially contaminated perineal care wipes. The contamination may cause skin irritation or increase infection risk.
Percussionaire Corporation is recalling Travel Air and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
Cardinal Health 200, LLC is recalling 344 Presource Packs containing Stryker tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Heraeus Medical is recalling PALACOS R pro 40 and 80 bone cement because of a potential for monomer liquid leakage. The recall affects 33,727 units distributed worldwide.
American Nitrile Operations LLC is recalling 17,481,000 Opportunity Pro nitrile gloves nationwide due to defects like tears and debris that may expose users to pathogens or chemicals.
Cardinal Health is recalling 3,677 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets because handpieces may leak fluid, creating a slip and fall hazard.
Heraeus Medical is recalling PALACOS MV pro 40 and 80 bone cement due to a potential for monomer liquid leakage. The recall covers all lot numbers distributed worldwide.
Shanghai United Imaging Healthcare is recalling four uCT 530 CT systems due to a software defect that may hide patient images, potentially requiring rescans.