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 21101–21120 of 38,428 recalls

May 1, 2018· TP Orthodontics, Inc.

Recalled Item: Jasper Vektor

The Issue: The firm has received 106 complaints of the

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

Class II — Potential Health HazardTerminated
April 30, 2018· Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

Recalled Item: PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿...

The Issue: A pinhole caused by the laser printer in

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

Class II — Potential Health HazardTerminated
April 30, 2018· Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc

Recalled Item: PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product

The Issue: A pinhole caused by the laser printer in

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

Class II — Potential Health HazardTerminated
April 30, 2018· Philips Electronics North America Corporation

Recalled Item: IntelliVue MX40 Patient Monitor

The Issue: Five warning statements are missing from the instructions

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

Class II — Potential Health HazardTerminated
April 30, 2018· Philips Electronics North America Corporation

Recalled Item: IntelliVue MX40 Patient Monitor

The Issue: Five warning statements are missing from the instructions

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

Class II — Potential Health HazardTerminated
April 30, 2018· Philips Electronics North America Corporation

Recalled Item: IntelliVue MX40 Patient Monitor

The Issue: Five warning statements are missing from the instructions

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

Class II — Potential Health HazardTerminated
April 30, 2018· Philips Electronics North America Corporation

Recalled Item: IntelliVue MX40 Patient Monitor

The Issue: Five warning statements are missing from the instructions

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

Class II — Potential Health HazardTerminated
April 27, 2018· GE Healthcare Japan Corporation

Recalled Item: GE Healthcare Revolution EVO

The Issue: GE Healthcare has identified that some CT systems

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

Class II — Potential Health HazardTerminated
April 27, 2018· GE Healthcare Japan Corporation

Recalled Item: GE Healthcare Optima CT660. The systems are intended for head

The Issue: GE Healthcare has identified that some CT systems

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

Class II — Potential Health HazardTerminated
April 27, 2018· GE Healthcare Japan Corporation

Recalled Item: GE Healthcare Optima CT660. Sold under the following product names:

The Issue: GE Healthcare has identified that some CT systems

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

Class II — Potential Health HazardTerminated
April 27, 2018· GE Healthcare Japan Corporation

Recalled Item: GE Healthcare Optima CT540. The systems are intended for head

The Issue: GE Healthcare has identified that some CT systems

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Ankle Arthrodesis Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Ankle Arthrodesis Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated
April 27, 2018· Stryker GmbH

Recalled Item: Femoral Nail

The Issue: The manufacturer has discovered that potentially out-of-specification products

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

Class II — Potential Health HazardTerminated