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.
Philips is recalling one S5-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling two L17-5 Ultrasound Transducers to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the X7-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the S4-1 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the 3D6-2 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling one C9-4 Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Philips is recalling the Mini Multi TEE Ultrasound Transducer to provide clarification and labelling that defines the useful life of ultrasound transducers in the field.
Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets because samples contained more active ingredient than labeled.
Shaman Botanicals is recalling White Vein Advanced Alkaloids Chewable Tablets because the active ingredient quantity exceeds the labeled specification.
Frito-Lay North America is recalling Miss Vickies Spicy Dill Pickle 8 oz bags that contain undeclared milk allergen. Affected products were distributed in Arkansas, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.
Saputo Cheese USA is recalling Great Value Fat Free Cottage Cheese Small Curd due to potential under-pasteurization caused by a broken seal on the pasteurizer. The product was distributed to multiple states.
Bluegrass Ingredients Inc. is recalling Butter-Rich Powder (50 LB. bags) due to potential Salmonella contamination. The product was distributed to Florida, Illinois, and Maryland.
Saputo Cheese USA is recalling Great Value Cottage Cheese products because a broken pasteurizer seal may have resulted in underpasteurized product. The recall affects 16oz, 24oz, and 3lb containers distributed to multiple states.
Dreamland Inc is recalling Zaatar Chickpea Salad distributed to Haggen stores in Washington because it contains undeclared sesame, soy, and wheat allergens not listed on the label.
Bluegrass Ingredients Inc. is recalling Butter Powder (50 LB bags, Product Number BDF0006, Lot 6018) due to positive Salmonella contamination. The product was distributed to Florida, Illinois, and Maryland.
Kradjian Importing Company is recalling MID EAST Jordanian Zaatar spice mix because it contains undeclared sesame and wheat, which are major allergens.
Cardinal Health is recalling Webcol Alcohol Prep pads because of non-sterility, with microbial contamination identified as Paenibacillus phoenicis. The FDA has classified this recall as Class I.
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423653, because the drainable large pouch may leak due to a manufacturing issue.
GE Medical Systems is recalling Centricity Universal Viewer software versions 6.0 through 6.0 SP10.4.1 because user login credentials may be exposed on the local client workstation.
Hologic is recalling one master lot of the Aptima HPV Assay because the product exhibits potential to generate either invalid or false negative results.
Baxter is recalling the Welch Allyn Spot Vision Screener VS100 on software version 3.2.0.1 because the display screen may unintentionally flicker, which may induce photosensitive seizure activity.
ConvaTec is recalling two lots of the EsteemBody Drainable Pouch, REF 423643, because the drainable large pouch may leak due to a manufacturing issue.
Clover Sonoma sour cream (8 oz and 16 oz sizes) is being recalled because a broken seal on the pasteurizer may have resulted in underpasteurized product. The recall affects multiple states including California, Washington, and others.
Abbott is recalling one lot of the ID NOW Influenza A & B 2 test after confirming the lot has a higher occurrence of invalid rates than stated in the Instructions for Use.
GE Medical Systems is recalling Centricity Universal Viewer software versions 5.0 SP6 through 5.0 SP7.1 because user login credentials may be exposed on the local client workstation.