Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Minimum severity
KMUYSL Big Red Barn Farm Animal Playsets are being recalled because the fence handles can detach and pose a choking hazard for children under 3 years old. The toy violates federal small parts regulations.
B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line due to blood gases adhering to tubing under negative pressure. Approximately 1.17 million units have been recalled in this Class I FDA action.
B. Braun Medical Inc. is recalling 3,158,104 hemodialysis bloodline sets due to a defect that can cause air bubbles to accumulate in the arterial line during dialysis treatment. The product is distributed worldwide including the United States and Canada.
Omnipod 5 insulin pump pods from 49 lots have a manufacturing defect causing internal insulin leakage instead of delivery to patients. This risks dangerous blood sugar complications including diabetic emergencies.
B. Braun has recalled hemodialysis bloodlines due to potential air bubble accumulation in the arterial line. The recall affects 4,848 units distributed nationwide and in Canada.
B. Braun is recalling hemodialysis bloodlines (Model SL-2000M2095L) due to potential air bubble accumulation in the arterial line under negative pressure. Approximately 328,640 units distributed worldwide are affected.
B Braun is recalling hemodialysis bloodlines (Model B3-4630M4705, 4,884 units) due to potential air bubble accumulation in the arterial line. Units manufactured since August 5, 2025 are affected and were distributed in the US and Canada.
B. Braun Medical is recalling hemodialysis bloodline sets due to potential air bubble accumulation in the arterial line. This Class I recall affects model SL-2010M2096 manufactured since May 25, 2025, distributed worldwide.
SLMD Benzoyl Peroxide Acne Lotion 2.5% is being recalled due to benzene contamination. The affected lots are 2691700 and 2691800, distributed nationwide.
Spectra Medical Devices is recalling 7,120,750 ampules of 0.9% Sodium Chloride Injection, USP, nationwide due to lack of sterility assurance. The product is used for intravenous, intramuscular, and subcutaneous injection.
Caring Mill Cough Drops (Menthol) distributed nationwide are being recalled following observations noted during an FDA manufacturing facility inspection on August 15, 2025. The affected product has lot number 20241030 and expiration date October 30, 2026.
Cipla USA is recalling Cinacalcet Hydrochloride tablets nationwide due to N-Nitroso Cinacalcet impurity exceeding acceptable daily intake limits. No illnesses have been reported.
Bupivacaine Hydrochloride injectable anesthetic is being recalled due to lack of assurance of sterility. Approximately 3.26 million ampules distributed nationwide are affected.
Huons Co., Ltd. is recalling Lidocaine Hydrochloride injection (1% 50mg/5mL) distributed nationwide due to lack of assurance of sterility. No illnesses have been reported.
HydroPeptide Clear Alliance Serum containing 2.5% benzoyl peroxide is recalled nationwide due to benzene contamination. Consumers with affected products should stop use immediately.
Lidocaine Hydrochloride injection vials are being recalled nationwide because manufacturers cannot guarantee the product's sterility. All lots within expiration are affected.
Quality Choice Honey Lemon cough drops are being recalled due to manufacturing quality issues identified during an FDA inspection. No illnesses or injuries have been reported.
3B Medical is recalling two units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet internal quality specifications and were inadvertently distributed. The FDA is overseeing the recall.
The FDA recalled 119 Arjo Tenor patient lifts because internal actuator components may fail to hold patients safely, risking sudden uncontrolled descent of the lifting arm.
Yeastone Broth culture medium may report incorrect antifungal susceptibility results during quality control testing. This could delay treatment response or necessitate switching antifungal agents.
Gentuity HF-OCT imaging systems with certain software versions may display repeated frames during pullback procedures, potentially affecting measurement accuracy. The issue affects 184 units distributed in the US and internationally.
THERAKOS CELLEX Photopheresis Systems are recalled due to difficulty installing the centrifuge bowl. Improper installation may cause the bowl to dislodge and break, delaying patient treatment and causing blood loss.
Philips AneurysmFlow software is recalled because the Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably indicate aneurysm treatment success, yet physicians are relying on it for clinical decisions.
Clariance-SAS is recalling Elegance Anterior Cervical Plates due to a quality issue involving the presence of burr on the finished product. The defect affects 511 units distributed across California, Illinois, New York, and Texas.
Integra LifeSciences is recalling Cytal Wound Matrix 2-Layer 5x5 cm due to increased endotoxin levels that exceed specifications. The recall affects 148 units distributed nationwide across 31 states.