Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise
While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
While total recalls and units affected declined in Q1 2025, the number of Class I events increased.
Devices are being removed from use after certain sizes were found to have smaller diameters than expected, potentially limiting airflow. Eight injuries have been reported.
Baxter is replacing faulty battery chargers in the Life2000 Ventilator system after identifying a defect that triggers alarms and renders the device inoperable.
The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.