These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.
2,775 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.
Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.
The Candy Barn recalled 665 packages of Chocolate Pecan Fudge on August 6, 2025. The product lacks proper allergen labeling for pecans and eggs, posing a high risk to consumers. The recall affects products distributed in Kalona, Iowa.
Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition Taurine Mental & Athletic Performance dietary supplement distributed nationwide. The FDA enforcement report cites unapproved drug claims and misbranding. Consumers who purchased this product should not consume it and should contact the company for refund or replacement.
Hi-Tech Pharmaceuticals recalled 85,950 units of Beta Sitosterol supplement distributed nationwide from Norcross, Georgia after regulators flagged unapproved drug claims and misbranding. The product claims cardiovascular support and cholesterol benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by letter.
Hi-Tech Pharmaceuticals recalled 85,950 units of Fish Oil Heart and Brain Health EPA/DHA Omega-3 soft gels distributed nationwide after regulators flagged unapproved drug claims. The FDA enforcement notice identifies unapproved health claims associated with the product. Consumers who bought this product should stop using it and contact Hi-Tech Pharmaceuticals for refunds or replacements.
Hi-Tech Pharmaceuticals recalled 85,950 units of Adderex XR Strongest Focusing Aid sold nationwide after regulators found unapproved drug claims and misbranding. The product claims to boost concentration without a prescription. Consumers who bought the product should not use it and should contact the company for a refund or replacement.
Westminster Pharmaceuticals is recalling Metoprolol Tartrate Tablets, 100 mg, 1,000-count bottles distributed nationwide in the United States. The recall concerns CGMP deviations that led to the presence of nitrosamine N-nitroso-metoprolol above the established ADI. Consumers should stop using the product and contact Westminster for guidance.
SeaSpine Orthopedics recalled 74 Reef TA Inserter instruments used with the Reef Interbody System, distributed worldwide to hospitals and surgical centers. The inserter may cause difficulty disengaging the implant or improper positioning, prolonging surgery and possibly requiring intraoperative revision. Hospitals and surgeons should stop using the device and follow recall instructions from SeaSpn
Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.
Philips Medical Systems recalled 810 Pinnacle Radiation Therapy Planning System units nationwide to healthcare providers. A software issue may cause an image error of the Region of Interest for HFP, FFS, and FFP orientations. Hospitals and clinics should stop using the software immediately and follow the manufacturer’s instructions.
Haleon US Holdings recalls 46,692 toothpaste tubes nationwide after a labeling mix-up. The outer carton says Fresh Mint, while the tube is labeled Cool Mint/Whitening; the tube contents are Fresh Mint as carton indicates. Consumers should stop using the product and contact Haleon for guidance.
Boston Scientific Corp. recalls 458 NephroMax Kit units using Encore 26 Inflation Devices after an internal review found foreign material particles could migrate from the inflation device into balloon dilatation catheters. The recall affects UPNs M0062101180 and M0062101600 worldwide. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions.
Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
M.O.M Enterprises recalled 85,248 units of Organic BABY bedtime drops sold through Multiple Retailers in 31 states. The product is a liquid dietary supplement for infants aged 4 months and older and may spoil due to yeast contamination. Consumers should not consume the product and should seek a refund or replacement from M.O.M Enterprises, LLC.
Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.
Tandem Diabetes Care recalled 122,958 insulin pumps nationwide in the United States, including Puerto Rico. A software defect in versions 7.9.0.1 and 7.10.1 for the t:slim X2 and version 7.9.0.1 for the Tandem Mobi paired with a Dexcom G7 sensor can trigger an unexpected automatic insulin correction bolus, raising the risk of hypoglycemia. Users should stop using the affected devices and follow a)
Hospira recalls 49,620 vials of Epinephrine Injection, distributed nationwide in the United States. The recall, active since August 4, 2025, targets vials with NDC 0409-4933-05 and case NDC 0409-4933-10. The hazard is lack of assurance of sterility. Health professionals should stop using the product and contact Pfizer or a healthcare provider for guidance.
B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.
Wasatch Photonics recalled 192 Raman spectrometers in the United States after identifying two potential laser safety failure modes. Models 785-SR-ILP, 785-SR-ILC, 830-SR-ILP, 830-SR-ILC, and 785-ER-ILC are included. The defect could occur under excessive force or extreme continuous vibration. Stop using immediately and follow the manufacturer’s recall instructions.
AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.