Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 361–372 of 4,586 recalls
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the f…
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators.…