The recall involves updating instructions for use, rather than removing devices from where they are used and sold ...
The FDA is elevating three sets of respiratory hardware recalls from Smiths Medical, covering portable ventilators and ...
The FDA's Center for Veterinary Medicine (CVM) announced Smiths Medical’s recall of the PneuPAC paraPAC Plus P300 and ...
The FDA and manufacturers routinely allow doctors and hospitals to continue using medical devices that could cause serious ...
ICU Medical Inc.’s ICUI subsidiary, Smiths Medical, has issued a recall for certain Bivona neonatal and adult tracheostomy ...
FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in ...
Ross Segan was chosen to lead the office, which handles premarket authorizations and recalls, in the agency’s Center for Devices and Radiological Health.
Cardiovascular devices with Class I recalls appear to be rarely subjected to premarket or postmarket testing, according to a ...
General Motors is recalling 13,241 of its 2024 GMC Canyon vehicles, the NHTSA report said. The automobile manufacturer said, ...
The majority of FDA-recalled devices made it to market via the 510(k) pathway, which doesn’t require new clinical or safety ...
Design defects in three popular models spur Anker's second recall this year. Here's what you should do right away.