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.
A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.
ARG Laboratories is recalling Pain Wizard pain relief cream due to propylene glycol used in manufacturing not meeting pharmaceutical grade specifications. The product was distributed nationwide.
The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.
Mirion Technologies is recalling the Captus 4000e Thyroid Uptake System due to complaints of unexpected collimator detachment. Affected users should contact the manufacturer for guidance.
Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.
Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.
Maribel's Sweets, Inc. is recalling its 7.7-piece Mother's Day heart box due to undeclared coconut. The product may pose a risk to consumers with coconut allergies. Approximately 4,011 boxes were distributed nationwide and through online retailers.
Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.
Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.
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.
Texas Pecan Co is recalling mixed nuts and dried fruits due to potential cross-contamination with allergens including milk, soy, sesame, and wheat. Consumers with allergies to these allergens should not consume the affected products.
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.
Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.
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.
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.
The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.
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.
Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.
Philips Allura Xper FD20 X-ray systems with ADN7NT patient tables may have a pivot brake failure after software upgrade 8.1.100 is installed. This could cause unexpected table movements during use.
Rubicon Research is recalling 11,664 bottles of Metoprolol Tartrate 25mg tablets nationwide due to the presence of metal in the tablets. Consumers should discontinue use and contact their healthcare provider.
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.
Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.
ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.