794 recalls tagged with “infant product”.
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.
Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.
Hi-Tech Pharmaceuticals recalled Joint-RX, a 600 mcg dietary supplement sold nationwide, after regulators flagged unapproved drug claims. The recall affects 85,950 units shipped to more than 40 states. Consumers should stop using the product and contact the company for refunds or replacements.
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.
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.
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
Glenmark Pharmaceuticals recalls 14,976 bottles of Carvedilol 25 mg distributed nationwide in the United States after FDA-identified NNCI impurity exceeds limits. The impurity prompted CGMP deviation findings. Consumers should stop taking the drug and contact Glenmark or a healthcare provider for guidance.
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.
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.
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 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.
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)
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.
FDA-listed recall for Hospira brand 8.4% Sodium Bicarbonate Injection affecting 15,750 vials distributed nationwide. The liable lot LH2671, expiring 11/30/2026, is linked to a lack of assurance of sterility. Healthcare providers and patients should stop use and contact Pfizer for guidance.
AVID Medical recalls 228 CPT BASIC IR PACKs sold nationwide, including Florida, due to open header bag seals that may compromise sterility. The recall is active as of September 17, 2025. Consumers should stop use and follow manufacturer 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.
B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.
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.
Beckman Coulter has issued a recall for 116 DxC 500 AU Module with ISE and DxC 500i components sold internationally. The recall date is 2025-08-04. A processing fault can cause the Clinical Chemistry test to stay In Progress when an Immunoassay test is run between CC tests. Delays may occur. Stop using the device and contact Beckman Coulter for instructions.