Category: FDA Updates

FDA Updates

FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns

Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.

FDA Updates

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.

FDA Updates

Smiths Medical Recalls Endotracheal Tubes Over Ventilation Risk

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.

Clearances

FDA OKs Inogen Simeox 200 Airway Clearance Device

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.

Recalls

Baxter Issues Correction for Life2000 Ventilator Due to Battery Charger Malfunction

Baxter is replacing faulty battery chargers in the Life2000 Ventilator system after identifying a defect that triggers alarms and renders the device inoperable.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

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.