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.

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.

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 ...

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 ...

(RTTNews) - The US Food and Drug Administration has annuonced that ICU Medical, Inc. is recalling Potassium Chloride Injection, 20 mEq and 10 mEq, citing mislabeling. The recall involves one lot ...

20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have inco View full recall details at FDA.gov Wild Coast Raw ...

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level.

Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with ...