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.
Hans Kissle Red Bliss Potato Salad is recalled because the top label identifies the product as potato salad but the unit contains pasta salad, leaving wheat undeclared. 66 units are affected.
MediHoney Hydrogel Adhesive Sheet dressings, catalog numbers 31722 and 31744, are recalled after packaging failures were identified that could breach the sterile barrier. 1,147 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs with flow stop, 50 mL, product code 21-7301-24, may have weakened medication bag welds that could allow leakage. 211,750 units are affected.
Maple Nut Fudge from The Candy Barn is recalled because the specific tree nut pecan and egg are not listed in the contains statement. 665 packages across the firm's products are affected.
Philips Azurion systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,861 units are affected.
Smiths Medical CADD Medication Cassette Reservoirs, 50 mL, product code 21-7001-24, may have weakened medication bag welds that could allow leakage. 29,811 units are affected.
Evergreen Farm Korean Pear Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 610 cases distributed in three states are affected.
Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.
Smiths Medical CADD Medication Cassette Reservoirs may have weakened medication bag welds along the bag perimeter, which could result in medication leakage. 265,500 units are affected.
Chocolate Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.
Semaglutide 2.5 mg/mL injection, 0.8 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 186 vials are affected.
Clean-tail Coconut Farm Raised Breaded Butterfly Shrimp in bulk master cartons, product of Indonesia, is recalled because it may be contaminated with Cesium-137. 31 cases are affected.
Peanut Butter Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.
Chocolate Walnut Fudge from The Candy Barn is recalled because the specific tree nut walnut and egg are not listed in the contains statement. 665 packages across the firm's products are affected.
Evergreen Farm Jujube Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 197 cases distributed in three states are affected.
Lemon Meringue Pie, 8-inch round, is recalled because FD&C Yellow No. 5 is undeclared on the label. The recall covers 136,252 cases distributed at retail across many states.
Evergreen Farm Grape Juice in 4 fl oz foil pouches is recalled for lack of pasteurization and sanitation records. 78 cases distributed in three states are affected.
Chocolate Mint Fudge from The Candy Barn is recalled because egg is not listed in the contains statement. 665 packages across the firm's products are affected.
Grandma's Old-Fashioned Peanut Brittle from The Candy Barn is recalled because peanuts and milk are missing from the contains statement. 665 packages across the firm's products are affected.
Smiths Medical CADD Yellow Medication Cassette Reservoirs with flow stop, 100 mL, product code 21-7300-24, may have weakened medication bag welds that could allow leakage. 289,098 units are affected.
CVS Honey Pads, catalog numbers 9370613 and 937404, are recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 111,492 units are affected.
Semaglutide 2.5 mg/mL injection, 4 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 648 vials are affected.
Superion Indirect Decompression System implants and kits are recalled because a product performance review found the device and instruments are not consistently meeting expected performance, including breakage. 70,516 units are affected.
Sterile Cover 10-Pack Shipper Box Assemblies are recalled because elastic bands in the kit may detach or fracture during surgery, risking retained foreign bodies and surgical site infection. 200 units are affected.
Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.