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 18421–18440 of 38,428 recalls

March 21, 2019· Edwards Lifesciences, LLC

Recalled Item: EV1000 Clinical Platform

The Issue: for an electrical short circuit leading to

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

Class I — Serious Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System 10 MM

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System 15 MM

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Conmed Corporation

Recalled Item: ConMed Anchor Tissue Retrieval System"

The Issue: Voids in the seal or a partial seal

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

Class II — Potential Health HazardTerminated
March 21, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: syngo.via syngo.CT Cardiac Function

The Issue: There is a potential risk of a wrong

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

Class II — Potential Health HazardTerminated
March 21, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: syngo.via syngo.CT Cardiac Planning

The Issue: There is a potential risk of a wrong

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

Class II — Potential Health HazardTerminated
March 20, 2019· Ortho-Clinical Diagnostics

Recalled Item: VITROS XT 7600 Integrated System

The Issue: for sample fluid to be dispensed to

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: NM/CT 870 CZT

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: NM 830 Product Usage: The Discovery NM 630 is an

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: NM/CT 860 Product Usage: The GE NM/CT 860 system is

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: NM/CT 850 Product Usage: The GE NM/CT 850 system is

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: Discovery NM/CT 670 CZT

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated
March 20, 2019· GE Healthcare, LLC

Recalled Item: Discovery NM 630 Product Usage: The Discovery NM 630 is

The Issue: During installation of certain Nuclear Medicine systems delivered

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

Class II — Potential Health HazardTerminated