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 27021–27040 of 38,428 recalls

May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color A3.5 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color Impulse violet

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color D4 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color Impulse blue

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color Impulse grey

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color B3 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color A4 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color Impulse brown

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color D2 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color B4 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color B2 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color C1 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color A3 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 27, 2016· Ivoclar Vivadent, Inc.

Recalled Item: Zenostar MT Color C3 60ml

The Issue: The primary packaging of these products may show

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

Class II — Potential Health HazardTerminated
May 26, 2016· Roche Diagnostics Operations, Inc.

Recalled Item: ONLINE TDM Vancomycin 100 tests

The Issue: Roche Diagnostics Operations, Inc. has issued a voluntary

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

Class II — Potential Health HazardTerminated
May 26, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704)

The Issue: Eight (8) issues were identified which may affect

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

Class II — Potential Health HazardTerminated
May 26, 2016· Medtronic Inc., Cardiac Rhythm and Heart Failure

Recalled Item: Medtronic

The Issue: Recently, a new software version was automatically sent

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

Class II — Potential Health HazardTerminated
May 26, 2016· Exactech, Inc.

Recalled Item: Novation Press-Fit Splined RDD

The Issue: Labeled with the incorrect Global Trade Item Number

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

Class II — Potential Health HazardTerminated
May 26, 2016· Exactech, Inc.

Recalled Item: Novation Press-Fit Splined RDD

The Issue: Labeled with the incorrect Global Trade Item Number

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

Class II — Potential Health HazardTerminated
May 26, 2016· Smith & Nephew, Inc.

Recalled Item: LEGION(TM) HK FEMORAL ASSEMBLY

The Issue: The surface inside of the femoral component, where

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

Class II — Potential Health HazardTerminated