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.
Baxter is correcting false upstream occlusion alarms in SIGMA Spectrum and Spectrum IQ infusion pumps following software upgrades affecting approximately 3,306 units distributed nationwide in the US.
Walmart's Great Value Sliced Strawberries are being recalled due to potential Hepatitis A contamination. Approximately 28,650 bags distributed across 32 states are affected.
SANTOS FROZEN FOODS is recalling Regular Deviled Crabs (4oz) for undeclared milk and sesame allergens. Approximately 520 cases were distributed domestically in affected lots beginning with 23 and ending in 03, 04, or 05.
Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.
The FDA has issued a Class I correction for Baxter's Spectrum IQ Infusion System due to increased false upstream occlusion alarms following software updates. Approximately 19,861 units are affected nationwide.
Dakota Style, Inc. is recalling salt and vinegar pretzel products nationwide because they may contain undeclared milk. Consumers with milk allergies should not consume these products.
Great Value Antioxidant Fruit Blend frozen berries are being recalled due to potential Hepatitis A contamination. The affected product was distributed across multiple states through Walmart, HEB, and Costco.
Gelson's Sea Salt Pretzels are being recalled nationally because they may contain undeclared milk. This poses a hazard to consumers with milk allergies.
EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.
Wawona Frozen Foods recalls Organic Daybreak Blend frozen strawberries sold at Costco due to potential Hepatitis A. Approximately 9,878 cases were distributed to Costco locations in five western states with lot codes dated through October 2023.
Dakota Style, Inc. is recalling multiple brands of dill pickle pretzels nationwide because they may contain undeclared milk, a major allergen. Consumers with milk allergies should not consume these products.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to out-of-specification conductivity, osmolality, and pH. The diluent may produce inaccurate blood cell test results.
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
L. Perrigo Company is recalling Picnic Fexofenadine Hydrochloride Tablets (180 mg) nationwide because the product failed impurity and degradation specifications. The affected lot is 2DR0471 with expiration date 12/23.
BASIC CARE ALLERGY (fexofenadine hydrochloride) 180 mg tablets are being recalled nationwide due to failed impurities and product degradation specifications. Approximately 11,904 cartons were affected.
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
EzriCare Artificial Tears eye drops are being recalled nationwide due to manufacturing facility contamination and CGMP deviations. The recall includes multiple lot numbers distributed nationwide.
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
Tampico brand Mango Punch (1 gallon) is recalled because it contains undeclared Yellow 5, a food dye that can cause reactions in people with tartrazine sensitivity.
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
Oregon Potato Company is recalling frozen berry products distributed nationwide under multiple brand names due to potential Hepatitis A contamination. Consumers who have purchased these products should not consume them.
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.