Recalls

Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.

Recalls

Philips Respironics Updates Use Instructions for Certain BiPAP Devices

Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.

Recalls

Zyno Medical Recalls Infusion Pumps Over Software Issue

Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.

Recalls

Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error

Philips Respironics is recalling certain DreamStation Auto CPAP and Auto BiPAP devices due to a programming error introduced during rework by a supplier.

FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall

Mar 5, 2025

The FDA has issued an early alert regarding Baxter’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing.

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.