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 18661–18680 of 38,428 recalls

March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Screw Tap Tapered WP Single-Pat - Product Usage: The Guided

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Abutment Screw Retrieval Kit - Product Usage: The kit itself

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage:

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument CC NP & Ext Hex WP 22

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument CC RP & Tri Ch Hex WP

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Kit - Product Usage: The kit itself does

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Nobel Biocare Usa Llc

Recalled Item: Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The

The Issue: Due to a problem in the packaging sealing

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

Class II — Potential Health HazardTerminated
March 14, 2019· Trilliant Surgical, LLC

Recalled Item: Gridlock Ankle Screw Driver Bit - Product Usage:

The Issue: A screwdriver used to facilitate implant insertion and

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

Class II — Potential Health HazardTerminated