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 15141–15160 of 38,428 recalls

April 24, 2020· LivaNova USA Inc.

Recalled Item: 3/8X3/8X3/8 Y CONN

The Issue: XXX

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: 1/4X3/8 REDUC CONN

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: 3/8 STR CONN

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: 1/2 - 3/8 REDUC CONN

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: 1/4X3/16X3/16YCONN

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24.

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· LivaNova USA Inc.

Recalled Item: Vein Irrigation Cannula with blunt tip. ASY BIC

The Issue: The firm has identified through internal tests that

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

Class II — Potential Health HazardTerminated
April 24, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Medtronic Bone Void Filler

The Issue: Product may not maintain its setting characteristics for

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

Class II — Potential Health HazardTerminated
April 24, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Extremities

The Issue: Product may not maintain its setting characteristics for

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

Class II — Potential Health HazardTerminated
April 24, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: Medtronic Bone Void Filler

The Issue: Product may not maintain its setting characteristics for

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

Class II — Potential Health HazardTerminated
April 24, 2020· Physio-Control, Inc.

Recalled Item: Infant Child Starter Kits

The Issue: Packaging of infant child reduced energy electrodes was

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

Class II — Potential Health HazardTerminated
April 24, 2020· Physio-Control, Inc.

Recalled Item: Infant/Child Reduced Energy Defibrillation Electrodes

The Issue: Packaging of infant child reduced energy electrodes was

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

Class II — Potential Health HazardTerminated