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 30841–30860 of 38,428 recalls

March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19

The Issue: The Universal Nut, a component of the orthodontic

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

Class II — Potential Health HazardTerminated
March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: HTM Mechanism Set Set 16

The Issue: The Universal Nut, a component of the orthodontic

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

Class II — Potential Health HazardTerminated
March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms

The Issue: The Universal Nut, a component of the orthodontic

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

Class II — Potential Health HazardTerminated
March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: Herbst Universal Nut which is used in a Herbst Appliance

The Issue: The Universal Nut, a component of the orthodontic

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

Class II — Potential Health HazardTerminated
March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies

The Issue: The Universal Nut, a component of the orthodontic

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

Class II — Potential Health HazardTerminated
March 9, 2015· Specialty Appliance Works, Inc.

Recalled Item: TS Crown Component 4UR (5/pk)

The Issue: The Universal Nut, a component of the orthodontic

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 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: Replace Select Tapered TiU 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: NobelReplace CC 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 PMC 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 Tapered Groovy 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 CC PMC 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· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC 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· Nobel Biocare Usa Llc

Recalled Item: NobelReplace CC 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 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 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· GE Healthcare

Recalled Item: Kenex Radiation Shield installed with GE Healthcare Interventional

The Issue: GE Healthcare has recently become aware of an

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 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 4.3x10mm

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 6.0 6x8mm

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