American Hospital Association

FDA issues most serious recall for certain pacemaker devices by Boston Scientific

The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software- ...
Medical Design & Outsourcing

FDA warns of neurosurgical device shortage after Medline recall

The FDA linked the shortage to a supplier issue, noting Medline Industries’ recent Class 2 recall of its neurosurgical sponge ...
RAPS

MedCon: FDA sees uptick in class I recalls in 2025 as it tackles resourcing issues

COLUMBUS, OH – The US Food and Drug Administration (FDA) saw more new recall events for class I medical devices in 2025 than it has in recent years, a trend that continues to trouble agency officials.
MassDevice

FDA issues Class I recall correction for Boston Scientific pacemakers

The FDA’s recall expands the scope of affected Boston Scientific pacemakers and introduces a new software update.

US FDA issues recall of Boston Scientific heart devices

May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug ...
JD Supra

FDA Class I Recall of FreeStyle Libre 3 Sensors: Practical Steps and Legal Considerations

The FDA has identified a Class I recall (its most serious type) involving certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. The reported issue is incorrect low glucose readings (lower than ...