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.
Herold Salads, Inc. is recalling Pasta Potpourri salad due to potential Listeria monocytogenes contamination. Affected products in 1 lb, 2 lb, and 5 lb containers were distributed in Ohio, Pennsylvania, and Michigan.
Procter & Gamble is recalling Old Spice Pure Sport Anti-Perspirant & Deodorant Spray (6.0 oz) due to potential benzene contamination risk from manufacturing facility CGMP deviations. All affected lots expire through September 2023.
PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.
VACUETTE blood collection tubes are missing an anticoagulant additive, causing samples to clot and producing inaccurate or absent lab results. This can delay diagnosis or lead to inappropriate treatment.
TreeHouse Foods is recalling multiple brands of 32oz Organic Chicken Bone Broth due to potential microbial contamination. The affected products were distributed across 42 US states.
Sweet and Simple Kettle Corn is recalling Cheddar Kettle Corn because its label fails to declare milk as an ingredient. Consumers with milk allergies may be at risk from consuming this product.
Maquet Cardiovascular is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System (model VH-3000-W) because polyimide particulate matter may be present on the device and could be introduced into arterial conduits during bypass graft surgery.
Olympus Corporation recalls 179 SOLTIVE SuperPulsed Laser Fibers due to potentially breached sterile pouch seals that could cause procedure delays or patient infections if not detected before use.
Maquet Lucea operating room light systems are being recalled due to a potential for the light to fall in the operating room. No injuries have been reported.
Procter & Gamble is recalling Old Spice SWEAT DEFENSE ULTIMATE CAPTAIN anti-perspirant spray due to potential benzene contamination at the manufacturing facility. Affected products have expiration dates through September 2023.
TreeHouse Foods is recalling vegetable broth sold under Essential Everyday, HEB Select Ingredients, and Chef's Cupboard brands due to potential microbial contamination. Products distributed to 37 states.
Randox Laboratories is recalling Calibration Serum Level 3 (CAL2351) distributed in the US and Puerto Rico because it exhibits a positive bias in CK Total measurements on RX Series instruments, potentially affecting test accuracy by up to 13%.
The Fillo Factory Inc. is recalling Wellsley Farms Assorted Mini Quiches due to possible aluminum foreign material contamination. Approximately 3,412 retail units distributed to stores across multiple states are affected.
The FDA is recalling Maquet Axcel and Axcel+ operating room light systems due to a potential for the light system to fall. The recall affects 236,793 units distributed nationwide and globally.
Getinge USA is recalling 236,793 Maquet Rolite operating room light systems due to a potential for the light fixture to fall. No injuries have been reported.
CVS Health Magnesium Citrate Saline Laxative Oral Solution in Grape flavor is being recalled due to microbial contamination with Acetobacter nitrogenifigens bacteria. Affected lot A80763 (expiration 11/2025) was distributed nationwide.
Philips Incisive CT systems with specific ECG cable may experience signal loss due to connector weakness, potentially delaying diagnosis.
TreeHouse Foods is recalling Imagine 32oz Bone Broth Chicken due to potential microbial contamination. The product was distributed across multiple states.
TreeHouse Foods is recalling Organic Low/Reduced Sodium Chicken Broth sold under multiple brands due to potential microbial contamination. The recall affects 439,240 cases distributed across 37 states.
Oakworks Inc is recalling Ultrasound EA examination tables because the backrest platform can develop stress fractures, making the table inoperable in inclined positions. Approximately 104 units distributed nationwide are affected.
Smiths Medical is recalling Medex 700PSI stopcocks with rotators due to a manufacturing defect affecting the O-ring seal. The defect may cause medication leakage and under-infusion during patient treatment.
A surgical guide used in knee replacement is recalled due to mislabeling showing incorrect dimensions. This could result in improper bone resection and implant fit, potentially extending surgery time.
Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.
TreeHouse Foods is recalling 439,240 cases of Natures Promise 32oz Organic Vegetable Stock due to potential microbial contamination. The product was distributed across multiple states.
Cook Medical is recalling MINC+ Benchtop Incubators that may lose temperature control when exposed to static electricity on the lid, potentially causing embryo damage that could require additional medical procedures.