The US Food and Drug Administration (FDA) has tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as ...

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 ...

The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall.

While the increase in recalls alone would be enough cause ... including pharmaceuticals and medical devices. This absence of easily accessible, credible safety information creates a significant ...

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 ...

Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...

Med-tech firms have gnashed their teeth for decades over the use of the term “recall,” given that some recalls are mere corrections to product labels while others entail a full product withdrawal. The ...

The company will keep the systems on the market but is asking providers to check devices for visible cracks and return ...

The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...

The U.S. Food and Drug Administration has issued an urgent recall for the JMCC5A Ni/TruAire-5 Oxygen Concentrator due to the device spontaneously catching fire.

sent all affected customers an urgent medical device correction and information about which patients may need their data reprocessed. This is a Class I recall, the FDA's most serious ...