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.
Gaws Gourmet Foods is recalling Gaw's Classic Italian sub due to undeclared sesame. The recall affects 699 units distributed in Michigan; consumers who are allergic to sesame should not consume the product.
Meridian Bioscience is recalling Para-Pak Zn-PVA stool specimen collection vials due to a manufacturing defect that may cause leakage and risk exposure to biological hazards.
Gaws Gourmet Foods is recalling Gaw's Ham & Cheddar Bagels due to undeclared sesame. The product label does not list sesame, posing a risk to consumers with sesame allergies.
Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.
Gaws Gourmet Foods recalls Gaw's XL Ham & Cheese sub sandwiches due to undeclared sesame, a major allergen. The recall affects 357 units distributed in Michigan.
Burn Boot Camp AFTERBURN grass-fed whey protein bars (Triple Chocolate with Almond Butter) are being recalled due to foreign material including disposable hairnet, shrink wrap, and parchment paper found in some units. Affected lots are 181, 184, and 187.
Medline is recalling 144 Leg bag devices (model REF URO12573) distributed in the US and Panama due to undeclared latex that may cause allergic reactions in sensitive users.
Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
BioReference Health is recalling the 4Kscore Test, a prostate cancer risk diagnostic test used nationwide. The recall follows mathematical modeling performed on over 3,000 specimens regarding digital rectal exam (DRE) information requirements.
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
GE HealthCare Definium Tempo and Tempo Pro X-ray systems may have been assembled with incorrect bolt torque, creating a risk that Overhead Tube Suspension components could fall.
The Sensica Urine Output System (SCCS1002) displays incorrect timestamps and monitoring data when connected to WiFi or internet due to a time synchronization issue. This malfunction affects the accuracy of patient monitoring records.
Ben E Keith Foods has recalled 1721 cases of frozen and refrigerated foods that were temperature abused during storage and transit. The temperature-compromised products were distributed to food service operations.
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.
Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.
Sheetz M.T.go! Double Dipped Chocolatey Peanut Butter Peanuts Snax Mix is being recalled because it contains undeclared soy. The product was distributed in North Carolina, Virginia, and West Virginia.
LGNDS LLC is recalling TYSON 2.0 Kava & Kratom Blend supplement because the product contains kratom, an unapproved food additive, and has a pH above safe levels for an acidified product.
Ben E Keith Foods is recalling 1,721 cases of frozen tilapia fillets and tuna loin products due to temperature abuse during transport. Products were distributed to food service operations.
Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.
Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.