FDA Flags Draeger Recall After Faulty Filters Linked to Injuries

The U.S. Food and Drug Administration (FDA) has issued a Class I recall, its most serious classification, for millions of Draeger’s SafeStar and TwinStar mechanical filters used in anesthesia and mechanical ventilation. The filters, manufactured at Draeger’s headquarters in Lübeck, Germany, were found to produce misleading carbon dioxide readings, potentially leading clinicians to deliver unnecessary or harmful treatments.

The recall, initiated in June and updated with a customer notice on July 22, affects four filter models totaling nearly 12 million devices. The FDA confirmed that serious injuries have been reported due to inaccurate capnography readings but did not disclose the number of cases. No deaths have been reported.

Draeger has instructed hospitals to stop using the affected filters immediately, remove them from stock, and arrange for returns and replacements. The devices are commonly used during surgery and in intensive care units.

16-08-2025