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 25861–25880 of 38,428 recalls

October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Reciprocating MICRO SAW

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Keyless Driver Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 14cm QD Angle Attachment Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Electric Handpiece EM Hand Control Product Usage: Electric system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: SMALL ATTACHMENT

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: IMRI AIR CONTROL Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 14cm QD Angle Attachment Product Usage: Product attachment

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: XMAX Motor

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 12.6CM TAPERED ATTACHMENT

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: System Console

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: STANDARD CRANIOTOME

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 11cm QD Angle Attachment Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: System Console

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Rotating Large Craniotome

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Bearing Sleeve

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: IMRI SHORT ATTACHMENT Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: 90 degree Contra Angle Attachment Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated
October 6, 2016· The Anspach Effort, Inc.

Recalled Item: Foot control irrigation system Product Usage: Pneumatic system

The Issue: Supplied Directions for Use (DFU) did not contain

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

Class II — Potential Health HazardTerminated