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

Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old.

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

The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues.

Listing of Medical Device 2024 Safety Communications

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

Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating.

Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.

Learn about the issue, the FDA’s recommendations and actions, how to report a problem, and contact information.

Equinoxe Shoulder Systems were packaged in defective bags. Potential risks including premature implant wear or failure, which may lead to additional surgery.