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 27001–27020 of 38,428 recalls

May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part #313.221

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # 313.232

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # SD313.011

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # 313.250

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part #313.231

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # 313.211

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # 313.212

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part # 313.946

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Screwdriver Blade

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Part #311.039

The Issue: DePuy Synthes is voluntarily initiating this recall due

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

Class II — Potential Health HazardTerminated
May 31, 2016· Synthes (USA) Products LLC

Recalled Item: Synthes Ti Button Plate 7 Holes

The Issue: DePuy Synthes is voluntarily initiating a recall due

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

Class II — Potential Health HazardTerminated
May 30, 2016· RAYSEARCH LABORATORIES AB

Recalled Item: Radiation Therapy Treatment Planning System

The Issue: For a treatment plan consisting of multiple beam

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

Class II — Potential Health HazardTerminated
May 27, 2016· Zimmer Biomet, Inc.

Recalled Item: ROSA Brain 3.0 Intended for the spatial positioning and orientation

The Issue: Insufficient amount of washers in the Telescopic Arm,

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 B1 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 A2 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 A1 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 orange

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 C4 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 D3 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 C2 60ml art. no. 681060. Product Usage:

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