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.
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Bobo's Oat Bars - Peach are recalled due to undeclared coconut. The recall affects approximately 10,800 units sold under Lot Code 3J27111.
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.
Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.
Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.
Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.
Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.
Brut Classic Antiperspirant & Deodorant in 4 oz and 6 oz aerosol cans is being recalled due to benzene contamination. The recall affects all lots distributed in the United States and Canada.
Sure Unscented Deodorant Aerosol is being recalled nationwide due to benzene contamination. Consumers should stop using affected cans and contact the manufacturer.
Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.
Sure Regular Antiperspirant Deodorant Aerosol (6 oz cans) sold nationwide in the US and Canada is being recalled due to benzene contamination. All lots expiring on or before August 2023 are affected.
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.