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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.

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Defibtech Recalls Chest Compression Devices for Malfunction

Defibtech is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.

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OptumHealth Recalls Nimbus II Plus Infusion Pumps

OptumHealth Care Solutions is recalling Nimbus II Plus infusion pumps due to multiple failure modes, following an InfuTronix recall.

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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.

Teleflex Recalls Certain Arrow Catheterization Kits

Apr 4, 2024

Teleflex is recalling the Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits after reports of issues.

Vyaire Recalls AirLife Resuscitators for Life-Threatening Defect

Mar 22, 2024

Vyaire Medical is recalling certain AirLife Manual Resuscitators due to a life-threatening manufacturing defect.

Philips Recalls BrightView Imaging Systems

Feb 9, 2024

Philips has recalled its BrightView SPECT imaging systems for a potential component failure that would cause parts to fall on the patient.

Philips Stops Selling Respiratory Products in the U.S.

Feb 5, 2024

Philips announced that it would stop selling CPAP or BiPAP sleep therapy devices and other respiratory care devices in the U.S.

GAO to Investigate FDA’s Medical Device Oversight

Jan 22, 2024

The Government Accountability Office (GAO) is launching an investigation into the U.S. FDA’s potentially ineffective policies for recalling medical devices, prompted by concerns raised by Senators Durbin and Blumenthal regarding the slow response to recalls of Philips Respironics CPAPs, BiPAPs, and mechanical ventilators.