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 33361–33380 of 38,428 recalls

April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: MOUSE 9732721 STERILE O-ARM 10PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: SPHERES 8801071 1/TRAY 12PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: TRAJ GUIDE KIT

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: BIT 9733516 2.9mm DRILL STERILE

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: SPHERES 8801075 5/TRAY 12PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: TRAJ GUIDE KIT

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: TUMOR RESECTION KIT 9733607 NON-INVASIVE

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: SHUNT KIT 9733605 NON-INVASIVE

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: INSTRUMENT TRACKER 9733533XOM ENT 1PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: DISP 9730950 STRL SPHERE

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: PIN

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: TUMOR RESECTION KIT 9733608 SKULL MOUNT

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: INST 9731132 KIT CR DRIVER 5PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: BIOPSY NEEDLE KIT

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: PATIENT TRACKER 9733534XOM ENT 1PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: PIN

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: BAG 9732315 MOUSE STERILE 15 PK

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: PACK 9731975 TUMOR RESECTION AXIEM CR

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated
April 24, 2014· Medtronic Navigation, Inc.

Recalled Item: DISP 9730951 STRL SPHERE

The Issue: Medtronic Navigation is recalling certain Medtronic single-use, disposable

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

Class II — Potential Health HazardTerminated