Category: Recalls

Recalls

FDA Issues Alert for Draeger Atlan Anesthesia Workstations

Draeger expands its correction for Atlan models due to potential mechanical ventilation failure.

Recalls

Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking

The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.

Recalls

Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk

The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.

Recalls

FDA Issues Alert for Draeger Atlan Anesthesia Workstations

Draeger expands its correction for Atlan models due to potential mechanical ventilation failure.

Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process

Sep 4, 2025

New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.

Hamilton Medical Removes Breathing Circuits Over Serious Ventilation Risk

Aug 29, 2025

The devices may have cracks that could lead to patient rebreathing of exhaled gases.

FDA Issues Class I Recall for Ambu Manual Resuscitators

Aug 29, 2025

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

FDA Announces Class I Recall for ICU Medical Infusion Pump

Aug 29, 2025

A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.