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

Device recalls are not one-size-fits-all. There are voluntary recalls and safety alerts, which the FDA stays fairly hands-off about. One example is ... from the mandatory letter, consider ...

Hologic Inc. has received a warning letter from ... the company's recall of the devices toward the end of last year. The agency’s letter to the Marlborough-based medical device company's ...

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