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 29501–29520 of 38,428 recalls

July 28, 2015· Beckman Coulter Inc.

Recalled Item: Access Thyroglobulin Assay

The Issue: Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent

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

Class II — Potential Health HazardTerminated
July 28, 2015· Siemens Healthcare Diagnostics Inc

Recalled Item: RAPIDPoint 500 Blood Gas Analyzer

The Issue: When both ports (Serial and Ethernet) are configured

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

Class II — Potential Health HazardTerminated
July 27, 2015· Leica Microsystems, Inc.

Recalled Item: The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The

The Issue: The ASP6025 Tissue Processor instrument is incorrectly getting

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

Class II — Potential Health HazardTerminated
July 27, 2015· Siemens Healthcare Diagnostics, Inc

Recalled Item: ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent

The Issue: Low red blood cell control recoveries and low

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

Class II — Potential Health HazardTerminated
July 27, 2015· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: Mindray DPM 7 Monitor

The Issue: The DPM 7 Monitors may display a black

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Transonic Systems Inc

Recalled Item: Transonic Flow Probe

The Issue: Software defect; programming errors in the blood flow

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

Class II — Potential Health HazardTerminated
July 27, 2015· Sunrise Medical (US) LLC

Recalled Item: Zippie IRIS Wheelchair. model EIZ5A in combination with option code

The Issue: Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with

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

Class II — Potential Health HazardTerminated
July 27, 2015· Sunrise Medical (US) LLC

Recalled Item: Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code

The Issue: Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with

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

Class II — Potential Health HazardTerminated
July 27, 2015· Advanced Sterilization Products

Recalled Item: CIDEX Activated Dialdehyde Solution

The Issue: Advanced Sterilization Products (ASP) is recalling the CIDEX

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

Class II — Potential Health HazardTerminated
July 27, 2015· Trumpf Medical Systems, Inc.

Recalled Item: Trumpf Ceiling Mounted Surgical Lighting Systems

The Issue: Complaints received of the front joint of the

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

Class II — Potential Health HazardTerminated
July 27, 2015· Cepheid

Recalled Item: Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number...

The Issue: Firm determined that some lots of CT/NG Swab

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

Class III — Low RiskTerminated