We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A lack of documented testing of updated instructions for use for cleaning a heater-cooler system has helped earn LivaNova an FDA warning letter. Read More
Following a rash of infections related to duodenoscopes, the FDA has given its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for its ED-530XT model. Read More
CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
ECRI Institute is raising safety concerns associated with medical devices ranging from flexible endoscopes to ventilators, calling for an increased awareness of hazards that the products pose to patients. Read More
Baxter International is voluntarily recalling four lots of intravenous solutions due to the potential for leaking containers and particulate matter. Read More
St. Jude Medical is recalling its Optisure dual coil defibrillation leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils. Read More
The FDA is ratcheting up requirements for surgical mesh for transvaginal repair of pelvic organ prolapse, issuing two final orders that address safety risks. Read More
The FDA has hit the Dutch Ophthalmic Research Center’s Zuidland, Netherlands, facility with a warning letter for manufacturing adulterated devices. Read More
The FDA says it has scheduled an inspection with Singapore-based Biosensors International, following an import alert that banned the company’s medical devices. Read More
Australia’s Therapeutic Goods Administration is stressing the need for protocols and procedures to help minimize the risks of using medical devices that run on batteries. Read More