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.
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HA7G, expiration 8/31/2027) due to contamination with glass mineral wool. The product was distributed nationwide.
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.
The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.
Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
Covidien is recalling McGrath Mac 2 disposable laryngoscope blades due to defective anti-fog coating that can cause condensation and vision obstruction. Approximately 42,367 units were distributed across the United States and internationally.
GlaxoSmithKline recalls TUMS Antacid 1000 mg Assorted Berries chewable tablets (lot HR6A) due to presence of glass mineral wool. The product was distributed nationwide.
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
Rise Baking Company is recalling Favorite Day Bakery demi French bread sold at Target due to plastic contamination. The affected bread poses a choking hazard and was distributed in California and Iowa.
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.
Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.
TUMS Antacid chewable tablets (Assorted Berries, 1000 mg, lot HR5W) are being recalled nationwide because some bottles contain glass mineral wool. Consumers should stop using affected bottles immediately.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.
Nature's Path Organic Pumpkin Spice Waffles are being recalled due to undeclared peanut allergen. About 6,908 cases were distributed across 17 states.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Pepsi Beverages is recalling Crush Orange Soda 24-packs due to plastic foreign material found in some cans. The recall affects 184 cases distributed in Minnesota with lot code JUL2924XXXXMC10243 and a best-by date of July 29, 2024.
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.
GlaxoSmithKline is recalling TUMS Antacid tablets (Lot HB2G) due to glass mineral wool contamination. Affected product was distributed nationwide.
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.