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.
Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.
Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.
H-E-B Creamy Creations Ice Cream is being recalled due to potential metal contamination. The 3-ounce 12-packs distributed in Texas with code dates 09/11/2024 through 09/21/2024 may be affected.
Maribel's Sweets is recalling Mother's Day love purse boxes because they contain undeclared coconut, which poses an allergen risk to consumers with coconut allergies.
Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.
Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.
Maribel's Sweets, Inc. is recalling 4,011 boxes of 6-piece signature ganache chocolate boxes due to undeclared coconut. Consumers with coconut allergies are at risk.
Lucid Diagnostics recalls EsophaCap esophageal diagnostic sponges due to risk of sponge detachment from string during device removal. No injuries have been reported.
Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.
ARG Laboratories recalls Pain Wizard topical pain relief nationwide due to out-of-specification active ingredient and violative-grade propylene glycol used in manufacturing. No illnesses reported.
Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical procedures.
Maribel's Sweets, Inc. is recalling 2pc signature Ganache boxes nationwide due to undeclared coconut allergen. Consumers with coconut allergies should not consume this product.
Maribel's Sweets is recalling Mother's Day ganache boxes due to undeclared coconut. Consumers with coconut allergies face risk of allergic reaction.
Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without system restart.
ARG Laboratories' Natural Pain Relieving Cream Golden Tiger is being recalled due to out-of-specification active ingredient and improper-grade propylene glycol used in manufacturing. No illnesses have been reported.
Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.
Medline is recalling 12,994 paracervical and pudendal procedure kits because the Trumpet Needle Guide ring can detach when excessive pressure is applied, potentially causing injury.
Maribel's Sweets is recalling 4,011 boxes of 4-piece ganache candy because they contain undeclared coconut, which poses an allergen risk to consumers with coconut allergies.
H-E-B Creamy Creations ice cream in 12-packs is being recalled due to potential metal contamination. Affected products have code dates from August 31 to September 3, 2024, and were distributed in Texas.
ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.
H-E-B Creamy Creations Chocolate Ice Cream 3-ounce 12-packs distributed in Texas are recalled due to potential metal contamination. Consumers should not consume the affected product.
Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.
CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.
Texas Pecan Co is recalling mixed nut and dried fruit products due to potential cross-contamination with milk, soy, sesame, wheat, tree nuts, and peanuts. Consumers with allergies should not consume the affected products.
ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to an active ingredient that does not meet specifications and violative grade propylene glycol used during manufacturing.