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.
Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.
Frobright Salsary, LLC is recalling San Juan Salsa Mild Salsa due to potential contamination with wood particles. The 14 oz refrigerated product was distributed in Alaska, Idaho, Oregon, and Washington.
Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.
Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.
Kenil Healthcare is recalling 9,984 tubes of Artridon topical analgesic (menthol and methyl salicylate) due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects units distributed in Delaware and North Carolina.
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 tubes distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to manufacturing deviations. The recall affects 150,768 tubes distributed in Delaware and North Carolina.
Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Kingskin SacaCallos 17% salicylic acid bottles are being recalled due to manufacturing deviations. The firm initiated the voluntary recall affecting approximately 9,000 bottles distributed in Delaware and North Carolina.
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.
Philips is recalling certain Ingenia Elition S MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Kenil Healthcare is recalling CURA HONGOS Antifungal Cream (Clotrimazole 1%, 2 oz tubes) distributed in Delaware and North Carolina due to CGMP (Current Good Manufacturing Practice) deviations detected during manufacturing.
Knockroe Inc is recalling Bonya Vanilla Yogurt Parfait (8oz) due to undeclared almonds, which pose a risk to consumers with almond allergies. The product was distributed to NY, PA, MA, and NJ.
Nipro Renal Solutions USA is recalling MedicaLyte Liquid Bicarbonate Concentrate (models BC+201 and BC+100) due to the potential presence of visible foreign matter in the product.
H&C Farms Raw Premium Tomatoes are being recalled due to potential Salmonella contamination. The recall affects tomatoes distributed to eight U.S. states.
Knockroe Inc is recalling Bonya Strawberry-Banana Yogurt Parfait (8oz) because the product contains undeclared almonds, which pose a risk to consumers with tree nut allergies.
Knockroe Inc is recalling Bonya Raspberry Yogurt Parfait (8oz) because it contains undeclared almonds, which pose an allergy risk. The recall affects 6,984 units distributed to NY, PA, MA, and NJ.
Baxter Healthcare Corporation is recalling Welch Allyn Life2000 Compressor units due to a cybersecurity vulnerability discovered during internal testing.
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.
Ray & Mascari, Inc. is recalling tomatoes sold in retail 4-count clam shell containers and bulk cardboard cases due to potential Salmonella contamination. Affected products were distributed in IN, KY, MA, MD, MI, NC, OH, PA, and WI.
Knockroe Inc is recalling Bonya Black Cherry Yogurt Parfait due to undeclared almonds, which pose a risk to people with tree nut allergies. The product was distributed in NY, PA, MA, and NJ.
Knockroe Inc is recalling Bonya Passion Fruit Yogurt Parfait (8 oz) due to undeclared almonds, which poses a risk to consumers with tree nut allergies. The product was distributed to New York, Pennsylvania, Massachusetts, and New Jersey.