The coiled cord on some Cardiosave IABPs may fail and cause an unexpected shutdown, interrupting therapy to the patient with no warning.

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events...

The FDA updates information on reports of squamous cell carcinoma in the capsule around breast implants.

Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers

The FDA expanded its evaluation of the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines

FDA determined that the risk of anaphylaxis following false negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies. Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in Prescribing Information.

Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.

Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the u

Learn more about the issue with the HLS Set Advanced, background, FDA recommendations and FDA actions

Learn more about the issue, recommendations, FDA actions and reporting problems to the FDA

Renuvion/J-Plasma device can be used for additional aesthetic skin procedures

El dispositivo Renuvion/J-Plasma puede utilizarse para otros procedimientos estéticos de la piel

Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. Use of contaminated eye ointment m

The FDA is evaluating the potential for exposure to airborne chemicals (formaldehyde, cyclohexanone, and other volatile chemicals) from neonatal incubators.

The FDA posts letters to health care providers about the safe use of medical devices.

Seattle, Washington, nanoMaterials Discovery Corporation is voluntarily recalling all lots of its Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue” in four fluid ounce spray dispenser packaging to the consumer level. Certain batches of the company’s Alcohol Antiseptic 80% Alcoho

The LeadCare tests are used to detect blood lead level but has risk of falsely low results.

Certain Philips Respironics Trilogy and Garbin ventilators are recalled due to foam adhesion failure and the risk of residual PE-PUR foam debris.

Safety mitigation issues including a failing ball screw and missing safety key may cause the 600/800 Series systems to fall on patients, leading to injury.