What is a Medical Device Recall?

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Early Alerts minimize time between FDA’s initial awareness of a potentially high-risk medical device removal or correction and FDA’s public communication

.This page includes a list of various resources offered by the FDA regarding recalls and alerts for medical devices
 

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.

3M is correcting their Ranger Blood/Fluid Warming System due to incomplete temperature and flow rate specifications on the label.

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

Abbott has issued new instructions on removing TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to tip detachment issues

FDA Updates Warning About Imported Cookware That May Leach Lead: August 2025. Retailers Should Not Sell and Consumers Should Not Use Certain Cookware Because of Their Potential to Leach Lead into Food When Cooking

mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.

FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.  

FDA alerts of risks with use of unauthorized infant monitoring devices, which have not been reviewed for safety and effectiveness.

mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.