Tag: FDA recall

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BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy

The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.

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FDA Issues Early Alert for Becton Dickinson Needle Sets Following Reports of Injuries and Deaths

The agency warns of a high-risk issue where needle components may lock during insertion, potentially delaying critical care.

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GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals

The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.

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BMC Medical Recalls APAP Devices Over Firmware Defect That Can Halt Therapy

The FDA classified the action as a Class I recall after the manufacturer determined that some devices may not have received a previous firmware upgrade.

GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk

Dec 16, 2025

GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.

Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue

Nov 26, 2025

The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.

NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations

Nov 24, 2025

The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.

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

Nov 20, 2025

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

FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set

Nov 20, 2025

The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.

ECRI Announces Winners of 2025 Alerts Impact Award

Nov 4, 2025

The annual award recognizes excellence in recall management among healthcare institutions worldwide.

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FDA Expands Early Alert Program for High-Risk Device Issues

The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.