As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

As per the FDA’s recall database, there are 4,727 packs/cases currently in circulation in the US. Sentec/Percussionaire sent all affected customers an Urgent Medical Device Notification in December ...

Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and ...

Medical device recall events in 2024 reached their highest level since 2020 and more than 10% of them involved the most ...

AdvaMed is urging Congress to address tariffs, streamline medtech coverage, update AI policies and improve FDA hiring.

Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration. The Accolade devices under recall include the ...

To date, there have been no reports of adverse events associated with the recall, the company added. ICU Medical's IV solution pull comes nearly two years after the company issued an FDA Class I ...

Volkswagen recall notification letters will be sent to all vehicle owners on or about April 18, instructing them to make an appointment with their respective dealer to remove the engine cover ...

FDA food recalls hit major brands like MadeGood, Lay’s, and Costco’s tuna. From contamination to ... [+] mislabeling, here’s what was pulled off shelves and why. From canned tuna recalls ...