Tag: FDA recall

All

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.

All

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.

All

GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk

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.

All

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.

FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller

Sep 23, 2025

The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.

Class I Recall Expanded for Alaris Pump Infusion Sets

Sep 18, 2025

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

Tandem Issues Correction for t:slim X2 Insulin Pumps

Sep 15, 2025

A faulty speaker wire can cause a malfunction that halts insulin delivery, prompting the US Food and Drug Administration to classify the action as a Class I recall.

Philips Recalls Reworked CPAP and BiPAP Devices Over Programming Error

Sep 15, 2025

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