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 27221–27240 of 38,428 recalls

April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT Flow 64-3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH Sys 40-3R to 40-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH 64-3R TruePoint

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph 16 TruePoint

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: SYS IVK

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT-X 4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph 6 TP 3R to 4R Upgrade

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph Sys 16-3R to 16-4R upgrade

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH 64-4R TruePoint w/TrueV

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT-S(40) 4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH 64 - 3 Ring

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH SYS 64-3R to 64-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT-S(64) 4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT-S(40) 3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: Biograph mCT-X 3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH 6 TruePoint

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT Flow Edge-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT S(20) - 3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT Flow 20-3R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated
April 22, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT Flow 40-4R

The Issue: Siemens Medical Solutions, Molecular Imaging has become aware

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

Class II — Potential Health HazardTerminated