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 28501–28520 of 38,428 recalls

December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548950 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548650 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· Xeridiem Mediem Medical Devices Inc

Recalled Item: EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD

The Issue: A feeding (reflux) valve leakage issue. The feeding

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

Class II — Potential Health HazardTerminated
December 23, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: safety latch mechanism failure. The safety latch,

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

Class II — Potential Health HazardTerminated
December 23, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: safety latch mechanism failure. The safety latch,

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

Class II — Potential Health HazardTerminated
December 23, 2015· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: safety latch mechanism failure. The safety latch,

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

Class II — Potential Health HazardTerminated
December 23, 2015· MOOG Medical Devices Group

Recalled Item: Moog Curlin Infusion

The Issue: Moog is recalling Curlin 4000, 6000, and PainSmart

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

Class II — Potential Health HazardTerminated
December 22, 2015· Applied Medical Resources Corp

Recalled Item: STD KIT GK260

The Issue: Applied Medical Resources Corporation is recalling CA500 Epix

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

Class II — Potential Health HazardTerminated