The FDA is adding hemodialysis bloodlines (also referred to as set, tubing, blood, with and without anti-regurgitation valve; product code FJK) to the Medical Device Shortage List because of recent supplier issues.
The FDA posts letters to health care providers about the safe use of medical devices.
Dr. Reddy’s Laboratories Ltd is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.
As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are ingredients in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as
Vaporizers Sevoflurane Quick-Fil and Maquet Filling mix oxygen and sevoflurane for anesthesia. This sevoflurane may degrade to toxic hydrogen fluoride.
Tack Endovascular System is used to repair artery dissection after angioplasty but ongoing user issues led Philips to discontinue use and distribution.
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial used with SmartDrive MX2+ Wheelchair Power Assist system may be unresponsive to users.
Biosense Webster updated Instructions for Use for Varipulse due to higher-than-anticipated incidence of peri-procedural stroke or transient ischemic attack.
Philips Allura and Azurion interventional fluoroscopy systems are used in operating rooms. Incorrectly positioned mattresses may cause patient falls and injuries.
ROi newborn kits include Neo-Tee T-Piece Resuscitators. The Neo-Tee may have an undersized controller spring that could affect patient breathing support.
Olympus Guide Sheath Kits collect samples from breathing organs through an endoscope. The tip of the guide sheath may detach during a procedure.
February 25, 2025 – Natural Dior LLC, is voluntarily recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins, to the consumer level. The product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erec
February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of
02/25/2025 Melville, NY. Ascent Consumer Products Inc. is voluntarily recalling one lot of SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System to the consumer level. The recall is being initiated due to a confirmed test result of microbial contamination of the product with Staphylococcus aureus (S
Boston Scientific is recalling pacemakers due to a manufacturing issue that may cause early device replacement.
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