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 21481–21500 of 38,428 recalls

March 23, 2018· BioMerieux SA

Recalled Item: The VITEK 2 Gram-Positive identification card (GP) is intended for

The Issue: A shipment to Guadeloupe suffered a temperature excursions

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

Class II — Potential Health HazardTerminated
March 23, 2018· BioMerieux SA

Recalled Item: The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for

The Issue: A shipment to Guadeloupe suffered a temperature excursions

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

Class II — Potential Health HazardTerminated
March 23, 2018· BioMerieux SA

Recalled Item: The VITEK 2 Gram Negative Susceptibility Card is intended for

The Issue: A shipment to Guadeloupe suffered a temperature excursions

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

Class II — Potential Health HazardTerminated
March 23, 2018· BioMerieux SA

Recalled Item: Oxidase Reagent (): This test is used to detect

The Issue: A shipment to Guadeloupe suffered a temperature excursions

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

Class II — Potential Health HazardTerminated
March 23, 2018· BioMerieux SA

Recalled Item: Color Gram 2 (COLOR GRAM 2 - F)

The Issue: A shipment to Guadeloupe suffered a temperature excursions

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 015

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 23, 2018· Medtronic Sofamor Danek USA Inc

Recalled Item: Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW

The Issue: Slot screw had an overall length of 15mm,

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 23, 2018· Straumann Manufacturing, Inc.

Recalled Item: Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number

The Issue: A change regarding the shelf life of a

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid E7 ultrasound system Product Usage: Vivid E7 is

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid E90 ultrasound system Product Usage: Vivid E80 /

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE LOGIQ E9 ultrasound system Product Usage: The device is

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid E95 ultrasound system Product The device is intended

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid 7 ultrasound system Product Usage: Vivid E7 is

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid E80 ultrasound system Vivid E80 / E90 /

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE Vivid E9 ultrasound system Product Usage: GE Vivid E9

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated
March 22, 2018· GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Recalled Item: GE LOGIQ 9 ultrasound system Product Usage: The device is

The Issue: The system side of the power cord may

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

Class II — Potential Health HazardTerminated