Recalls

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

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.

Recalls

FDA Issues Early Alert on Infusion Pump Issue from Baxter

The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.

Recalls

Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection

Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.

Recalls

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

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.

Medical Device Recalls Reach Highest Level in Four Years

Feb 18, 2025

Sedgwick brand protection releases a year-in-review analysis of 2024 recall data, including the top five failures for medical devices.

Abiomed Updates Use Instructions for Impella RP Pumps Due to Device Interaction Risk

Feb 14, 2025

Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.

Baxter Issues Correction for Life2000 Ventilator Due to Battery Charger Malfunction

Feb 5, 2025

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