medtechdive10h
Device industry scrambles as FDA job cuts cause delays
The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...
aha.org1d
ICU Medical recalls certain lots of potassium chloride injection bags due to mislabeling
The Food and Drug Administration Feb. 18 announced that ICU Medical is voluntarily recalling certain lots of its potassium ...
Becker's Hospital Review1d
J&J heart pumps recalled over safety concerns
The Class I recall warned that the tip of guidewires or other medical devices may come into contact with the Impella pump during insertion, adjustment or removal. This interaction could result in ...
Medscape2d
Urgent Recall for Abiomed Heart Pumps
Abiomed has issued an Urgent Medical Device Correction updating the instructions for its Impella RP with SmartAssist and also its Impella RP Flex with SmartAssist heart pumps. The US Food and Drug ...
Becker's Hospital Review13d
4 recent medical device recalls and corrections
JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...
ABC718d
Gerber recalls, discontinues baby teething sticks over possible choking hazard
A baby food maker is recalling edible sticks meant to ease teething pain over a possible choking hazard Gerber said it was working with the U.S. Food and Drug Administration on the recall.
pharmaphorum20d
Device ad-vice: Best practices for handling a medical device recall
Product recalls are a major headache for pharma ... with extensive experience in medical device, biotechnology and pharmaceutical marketing. A graduate of the University of Texas, Amy joined ...
Sky20d
Major recall ordered of soft drinks made at Coca-Cola factory over potential health risks
The Food Standards Agency (FSA) has not yet issued a recall in the UK but is "investigating if any Coca-Cola products containing 'higher levels' of a chemical called chlorate are on the UK market ...
USA Today22d
FDA upgrades Frito-Lay potato chips recall to highest risk level due to undeclared milk
Federal regulators have upgraded a product recall of Lay's Classic Potato Chips to the highest risk level for a batch that may contain undeclared milk ingredients. Last month, Frito-Lay issued a ...
Forbes23d
Why Lay’s Potato Chip Recall Was Elevated To FDA’s Deadliest Category
Find out why the Lay’s potato chips recall for undeclared milk became a Class I warning and what ... [+] this means for consumers with allergies in the U.S. Lay’s potato chips, a pantry staple ...
New York Post23d
Lay’s potato chip recall classified at highest risk level, consumption ‘could cause death’
Federal health authorities have upgraded their recall of 13-ounce bags of Frito-Lay potato chips over fears that consuming the products, which may contain undeclared milk, could potentially be fatal.