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 21161–21180 of 38,428 recalls

April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA"

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083...

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS)

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180)

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 26, 2018· COVIDIEN MEDTRONIC

Recalled Item: BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC...

The Issue: Device may be missing a sled component. The

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

Class II — Potential Health HazardTerminated
April 25, 2018· Intersurgical Inc

Recalled Item: Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm

The Issue: When assembling an HME or Filter on this

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

Class II — Potential Health HazardTerminated
April 25, 2018· Baxter Healthcare Corporation

Recalled Item: Baxter EXACTAMIX Inlet

The Issue: Specific lots of EXACTAMIX Inlets listed below due

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

Class II — Potential Health HazardTerminated
April 25, 2018· Baxter Healthcare Corporation

Recalled Item: Baxter EXACTAMIX Inlet

The Issue: Specific lots of EXACTAMIX Inlets listed below due

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

Class II — Potential Health HazardTerminated
April 25, 2018· Baxter Healthcare Corporation

Recalled Item: Baxter EXACTAMIX Inlet

The Issue: Specific lots of EXACTAMIX Inlets listed below due

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

Class II — Potential Health HazardTerminated
April 25, 2018· Baxter Healthcare Corporation

Recalled Item: Baxter EXACTAMIX Inlet

The Issue: Specific lots of EXACTAMIX Inlets listed below due

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

Class II — Potential Health HazardTerminated
April 25, 2018· ConvaTec, Inc

Recalled Item: Convatec Esteem(TM) Synergy Stomahesive(R)

The Issue: It was discovered that the stoma hole of

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

Class II — Potential Health HazardTerminated
April 25, 2018· Conseal International, Inc.

Recalled Item: Nanosil Spray Gel

The Issue: A recent FDA inspection of the firm revealed

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

Class II — Potential Health HazardTerminated
April 24, 2018· Medtronic Inc.

Recalled Item: Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554

The Issue: The MiniMed Paradigm Veo insulin pump has an

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

Class II — Potential Health HazardTerminated
April 24, 2018· Biocare Medical, LLC

Recalled Item: Vulcan Fast Red Chromogen Kit 2

The Issue: Chromogen failed to develop due to a stability

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

Class II — Potential Health HazardTerminated