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 27201–27220 of 38,428 recalls

April 25, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba America Medical Systems

The Issue: It has been found that if the scan

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

Class II — Potential Health HazardTerminated
April 25, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba America Medical Systems

The Issue: It has been found that if the scan

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

Class II — Potential Health HazardTerminated
April 25, 2016· GSK Consumer Healthcare

Recalled Item: Breathe Right Clear

The Issue: Some cartons used in the secondary packaging of

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

Class III — Low RiskTerminated
April 25, 2016· Siemens Medical Solutions USA Inc.

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

The Issue: The bracket that is used to lift the

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

Class II — Potential Health HazardTerminated
April 25, 2016· Siemens Medical Solutions USA Inc.

Recalled Item: BIOGRAPH mCT S(20) - 4R

The Issue: The bracket that is used to lift the

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

Class II — Potential Health HazardTerminated
April 25, 2016· Siemens Medical Solutions USA Inc.

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

The Issue: The bracket that is used to lift the

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

Class II — Potential Health HazardTerminated
April 25, 2016· Siemens Medical Solutions USA Inc.

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

The Issue: The bracket that is used to lift the

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

Class II — Potential Health HazardTerminated
April 25, 2016· Volcano Corporation

Recalled Item: Volcano s5

The Issue: Volcano has become aware of an incompatibility issue

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

Class II — Potential Health HazardTerminated
April 24, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba American Medical Systems Celesteion

The Issue: degradation of detector performance

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

Class II — Potential Health HazardTerminated
April 22, 2016· Acumedia Manufacturers, Inc.

Recalled Item: Tryptic Soy Agar

The Issue: light precipitate may form in prepared plates of

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

Class II — Potential Health HazardTerminated
April 22, 2016· Epimed International, Inc.

Recalled Item: 15 g R.K. Epidural Needle (TW)

The Issue: There is a possibility that the needles may

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 20-4R

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: 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 40 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(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 mCT Flow 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 Flow 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 40-3R to 64-3R 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 6-4R 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(20)-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