ORAL/NASAL Endotracheal Tubes keep air flowing through a patient’s airway, but some tubes may be smaller in diameter than expected.

Software from Alaris System Manager and CCE Infusion Adapter needs updates so outdated infusion information does not load to the Alaris infusion pump system.

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

A manufacturing error may cause ProPort Plastic Implantable Ports, which are used in patients who need repeat venous access for treatment, to separate before, during, or after implantation.

Pipeline Vantage Embolization Devices block off blood flow to intracranial aneurysms. Some devices do not attach properly or fail to stay attached.

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the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.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.