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.
F.H. INVESTMENTS is recalling Estradiol 37.5 mg sterile pellets (Lot 253000125) due to potential metal particulate matter contamination. Affected product distributed nationwide.
Fresenius Kabi Compounding is recalling one lot of acyclovir sodium 200 mg intravenous injection due to lack of assurance of sterility. The affected product was distributed nationwide.
F.H. Investments is recalling Estradiol 15 mg sterile pellets nationwide due to potential metal particulate contamination. No illnesses have been reported.
Asteria Health recalls testosterone pellets nationwide due to potential metal particulate contamination. About 70,959 units are affected.
F.H. INVESTMENTS (Asteria Health) is recalling Estradiol 18 mg sterile implant pellets nationwide due to potential metal particulate matter. No illnesses have been reported.
Asteria Health is recalling testosterone and triamcinolone pellets (Lot 256000103) nationwide due to potential metal particulate matter contamination. No illnesses have been reported.
Asteria Health is recalling 50,990 Estradiol 6 mg sterile pellets nationwide due to potential metal particulate matter contamination. Patients should stop use and contact their healthcare provider.
Leksell GammaPlan software versions 11.3 and 11.4 contain an error in stereotactic reference definition that may cause treatment plans to irradiate incorrect patient locations if the error goes undetected.
Medline Industries recalls 7,380 medical convenience kits nationwide due to potentially open seals on BD ChloraPrep Triple Swabstick applicators, which could affect product sterility.
Philips has recalled the Azurion 7 M12 imaging system because the examination table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is active. This could pose a patient safety risk.
Philips is recalling the Azurion 7 M20 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. Approximately 5,136 units are affected worldwide.
The Philips Azurion 7 B12 medical imaging system may experience unexpected table movement when the Reset Geometry button is pressed, even if the table lock is engaged. This could affect patient safety during medical procedures.
Medline Industries is recalling 450 pediatric catheter securement dressing kits nationwide due to potential open seals on BD ChloraPrep applicator packaging. Open seals may compromise product sterility and integrity.
Philips Azurion 5 M12 imaging system tables may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active, posing a safety risk during medical procedures.
AVID Medical is recalling Halyard Transport Bag Kits (Kit Code LIFE0080-01) due to a Tyvek bag seal defect that may compromise the sterility of the kit. No illnesses or injuries have been reported.
Alphatec Spine, Inc. is recalling ATEC Lateral Navigation Disc Prep Instruments due to a design issue affecting the navigated array connection geometry. These surgical instruments may not function properly during spine surgery procedures.
Karison brand Punjabi Pinni (12 oz) is recalled because milk, a common allergen, is not listed on the ingredient label. The product was distributed in NY, NJ, and VA.
MG Foods is recalling Spicy Breakfast Burritos (10 oz, UPC 100001-00029 7) manufactured in Oak Creek, Wisconsin, due to small hard plastic fragments. Consumers should discard the product or return it to the retailer.
TKS Co-pack Manufacturing is recalling Aonic Complete Hers dietary supplement due to possible contamination with coliforms, E. coli, and Pseudomonas aeruginosa. The affected product was distributed in Utah.
Carrot Top Kitchens is recalling Lime Ginger Hummus because it contains undeclared sesame. Consumers with sesame allergies should not consume this product.
Karison brand PANJIRI is being recalled because milk is undeclared on the ingredient label. The product was distributed in New York, New Jersey, and Virginia. Consumers with milk allergies should discard or return it.
Ventura Foods LLC is recalling Creamy Peanut Butter and Strawberry Jam Poco Pac products distributed nationwide due to blue plastic contamination found during production. No illnesses have been reported.
Aonic Inc. is recalling Aonic Complete His dietary supplement drink shots due to possible contamination with coliforms, E. coli, and Pseudomonas aeruginosa. Approximately 780 bottles distributed in Utah.
Island Crab Corporation is recalling Smoked Grouper Dip sold in Florida due to undeclared milk, eggs, and sodium metabisulfite. Consumers allergic to these ingredients should not consume the product.
Medline is recalling specific circumcision kits due to potentially open seals on sterile applicators that could compromise sterility. This affects 168 units distributed nationwide.