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 3121–3140 of 38,428 recalls

December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Infinia I

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM/CT 670 CZT

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM/CT 670 DR

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM/CT 670 ES

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM/CT 670

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Infinia II

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Infinia II Hawkeye 4

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Infinia I Hawkeye 1

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· Tornier S.A.S.

Recalled Item: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide

The Issue: The Pin Guide is being recalled because the

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Optima NM/CT 640

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM 630

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Discovery NM/CT 670 PRO

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Recalled Item: GE Healthcare Varicam Millennium VG Discovery VH

The Issue: GE HealthCare has become aware that certain Infinia,

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

Class II — Potential Health HazardOngoing
December 18, 2024· Encore Medical, LP

Recalled Item: EMPOWR 3D Knee Tibial Insert

The Issue: 5R 16MM knee tibial insert package may contain

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

Class II — Potential Health HazardOngoing
December 18, 2024· Braemar Manufacturing, LLC

Recalled Item: Monitoring Service Application (MSA). Software to process

The Issue: Not all Electrocardiogram (ECG) events received July 2022-July

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

Class I — Serious Health HazardOngoing
December 16, 2024· Augustine Temperature Management, LLC

Recalled Item: Hot Dog PATIENT WARMING

The Issue: There is over-molding that stabilizes the connection between

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

Class II — Potential Health HazardOngoing
December 16, 2024· Augustine Temperature Management, LLC

Recalled Item: Hot Dog PATIENT WARMING

The Issue: There is over-molding that stabilizes the connection between

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

Class II — Potential Health HazardOngoing
December 16, 2024· Augustine Temperature Management, LLC

Recalled Item: Hot Dog PATIENT WARMING

The Issue: There is over-molding that stabilizes the connection between

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

Class II — Potential Health HazardOngoing
December 16, 2024· Integra LifeSciences Corp.

Recalled Item: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model

The Issue: for certain SKUs and lot numbers were

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

Class II — Potential Health HazardOngoing
December 16, 2024· Integra LifeSciences Corp.

Recalled Item: CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model

The Issue: for certain SKUs and lot numbers were

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

Class II — Potential Health HazardOngoing