Reprocessed medical devices recalled | CGM sensor issue linked to 860 serious injuries | Managing patients with high-risk leads

The FDA has announced seven Class I recalls related to this issue. Customers are urged to destroy the devices immediately instead of returning them to the manufacturer. 

Abbott first warned the public about this problem in November. Now, for the second time in less than a month, the FDA is providing additional details. 

There is a risk of users making adjustments during treatment that are unnecessary. The FDA is still evaluating the issue at this time.

HRS has shared an updated guidance on managing Boston Scientific defibrillation leads at risk of experiencing a significant malfunction. The issue, first reported in July 2025, is believed to impact approximately 350,000 leads still being used today.

Several detachable coil systems are being recalled due to a higher-than-expected failure to detach rate. Customers should not use them going forward.

New Jersey-based Zydus Pharmaceuticals has recalled nearly 23,000 bottles of its icosapent ethyl capsules due to leakage issues that may have weakened their effectiveness. 

This product was distributed throughout the United States from April 2022 to December 2025. Customers have been warned to stop taking it immediately.