Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 4841–4860 of 38,428 recalls

May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Smiths Medical ASD Inc.

Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube

The Issue: Smiths Medical has identified that the securement flange

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
May 29, 2024· Getinge Usa Sales Inc

Recalled Item: ALPHAMAXX Mobile Operating Table

The Issue: The recall is prompted by a defective charger

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 29, 2024· Getinge Usa Sales Inc

Recalled Item: ALPHAMAXX Mobile Operating Table

The Issue: The recall is prompted by a defective charger

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 29, 2024· Cardinal Health 200, LLC

Recalled Item: Presource kits and trays

The Issue: Cardinal Health is following the FDA's recommendations regarding

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
May 29, 2024· Getinge Usa Sales Inc

Recalled Item: ALPHAMAXX Mobile Operating Table

The Issue: The recall is prompted by a defective charger

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing