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 30241–30260 of 38,428 recalls

April 23, 2015· Covidien LLC

Recalled Item: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Covidien LLC

Recalled Item: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr

The Issue: Catheters may not meet antimicrobial specification

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

Class II — Potential Health HazardTerminated
April 23, 2015· Philips Medical Systems, Inc.

Recalled Item: Pinnacle3 Software Version 10.0

The Issue: A problem (the dose computed in planning mode

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

Class II — Potential Health HazardTerminated
April 22, 2015· Windstone Medical Packaging, Inc.

Recalled Item: Foot Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part

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

Class II — Potential Health HazardTerminated
April 22, 2015· Windstone Medical Packaging, Inc.

Recalled Item: Spine Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part

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

Class II — Potential Health HazardTerminated
April 22, 2015· Windstone Medical Packaging, Inc.

Recalled Item: Transvaginal Pack

The Issue: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part

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

Class II — Potential Health HazardTerminated