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.
TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.
Pacific Coast Fresh CO is recalling King Harvest Balsamic Hummus due to the presence of plastic fragments. The recall affects products distributed in Idaho, Oregon, and Washington with expiration dates in February 2025.
Jesse's Bakery is recalling Pan de Coco coconut rolls distributed in Hawaii because they contain undeclared milk, a common allergen that could harm people with milk allergies.
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.
Safecor Health is recalling 1535 Ferrous Sulfate 7.5 mg oral syringes distributed nationwide due to leakage observed during repackaging. The defective delivery system could result in improper dosing of the iron supplement.
King Harvest Black Olive Hummus (10 oz) has been recalled due to the presence of plastic fragments. The voluntary recall affects 4,019 cups distributed in Idaho, Oregon, and Washington.
Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.
Pacific Coast Fresh Co recalled King Harvest Classic Hummus because plastic fragments were found in the product. Approximately 10,142 cups were distributed in Idaho, Oregon, and Washington.
Pacific Coast Fresh CO recalled King Harvest Toasted Onion Hummus for possible plastic fragments. Affected product was distributed in Idaho, Oregon, and Washington.
MIM radiological software versions 7.2.0-7.2.6 may produce incorrect readings when fusing images with different fields of view, which could affect diagnostic accuracy.
Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.
Pacific Coast Fresh CO is recalling 1953 cups of King Harvest Chipotle Hummus due to potential plastic fragments in the product. The affected hummus was distributed in Idaho, Oregon, and Washington.
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.
Pacific Coast Fresh Co is recalling King Harvest Spinach Hummus due to plastic fragment contamination. Affected products were distributed in Idaho, Oregon, and Washington with expiration dates in February 2025.
Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.
Pacific Coast Fresh Co is recalling King Harvest Roasted Pepper Hummus due to potential plastic fragment contamination. The voluntary recall affects 9,535 units distributed in Idaho, Oregon, and Washington.
Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
Safecor Health, LLC is recalling Lorazepam 0.5 mg oral syringes nationwide due to a defective delivery system that causes leakage after repackaging.
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.
King Harvest Roasted Garlic Hummus is being recalled for possible plastic fragment contamination. The voluntary recall affects 9,588 cups distributed in Idaho, Oregon, and Washington.
Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.