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 30861–30880 of 38,428 recalls

March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC RP 5.0x10mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC RP 4.3x11.5mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU NP 3.5x13mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC PMC NP 3.5x11.5mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU WP 5.0x10mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobRpl Tapered Groovy 6.0mm 6x11.5mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU NP 3.5x16mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· CooperSurgical, Inc.

Recalled Item: WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001

The Issue: Internal gas line may malfunction causing the line

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU WP 5.0x13mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC RP 5.0x13mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC RP 4.3x13mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: Replace Select Tapered TiU NP 3.5x10mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC RP 5.0x8mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC PMC RP 4.3x10mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Nobel Biocare Usa Llc

Recalled Item: NOBELREPLACE Tapered Groovy RP 4.3x8mm

The Issue: A material used in the packaging of the

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

Class II — Potential Health HazardTerminated
March 9, 2015· Bacterin International, Inc.

Recalled Item: Instrument Kit for use with OsteoSponge SC grafts. The Instrument

The Issue: Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet

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

Class II — Potential Health HazardTerminated
March 9, 2015· GE Healthcare

Recalled Item: GE Healthcare

The Issue: GE Healthcare has become aware of a potential

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

Class II — Potential Health HazardTerminated
March 9, 2015· Siemens Medical Solutions USA, Inc

Recalled Item: MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A

The Issue: The gradient output supervision was permanently turned off

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

Class II — Potential Health HazardTerminated
March 9, 2015· In2Bones, SAS

Recalled Item: DUAFIT(R) PIP 0o CA SIZE 3

The Issue: Dimensional non-conformity leading to the impossibility to introduce

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

Class II — Potential Health HazardTerminated
March 9, 2015· In2Bones, SAS

Recalled Item: DUAFIT(R) PIP 0o CA SIZE 2

The Issue: Dimensional non-conformity leading to the impossibility to introduce

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

Class II — Potential Health HazardTerminated