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.
Hobbs Medical recalls Posi-Stop Injection Needles because manufacturing debris in the needle can block injection solution flow.
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.
Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Lot H11-23-057) because some units contain manufacturing debris that blocks the needle opening, preventing injection solutions from flowing properly.
NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.
Safecor Health is recalling specific lots of Vitamin D3 25 mcg tablets due to a manufacturing defect where blister card-foils may separate from the blister cavity. No illnesses or injuries have been reported.
Nestle Health Science is recalling Douglas Labs Stress-B-Plus Dietary Supplement due to incorrect formulation. The product contains Niacin as Nicotinic acid but the label states Niacinamide.
Safecor Health, LLC is recalling 1,470 boxes of Aspirin 81 mg chewable tablets nationwide due to a manufacturing defect where blister card-foils are separating from the blister cavity.
Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.
Padagis is recalling 10,872 jars of Triamcinolone Acetonide Cream USP 0.025% nationwide because some jars contain subpotent or superpotent active ingredient levels. The defect was discovered during long-term stability testing.
Safecor Health recalls 791 boxes of Calcium Carbonate chewable tablets (Lot 24A0073) due to cGMP deviations where blister card-foils separated from blister cavities.
Safecor Health is recalling certain Vitamin B1 supplements due to manufacturing defects where blister card-foils are separating from the blister cavity.
Dr. Reddy's Laboratories is recalling ibuprofen 600 mg tablets for failed tablet specifications. The affected product was distributed nationwide.
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Taylor Farms Colorado is recalling 42 cases of raw yellow onions in 5-lb bags distributed to food service facilities across six states due to potential E. coli O157:H7 contamination.
Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.
Taylor Farms Colorado is recalling raw yellow onions distributed to food service facilities in six states due to potential E. coli O157:H7 contamination. Use-through dates range from October 16 to November 3, 2024.
ImperialFresh processed fajita peppers made by FreshPoint Denver, Incorporated have been recalled due to potential E. coli O157:H7 contamination. Seven cases distributed in Colorado are affected.
Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.
Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.
Taylor Farms Colorado is recalling 615 cases of raw yellow onions for potential E. coli O157:H7 contamination. Affected food service facilities are in CO, KS, MO, NE, NM, and UT.