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 25621–25640 of 38,428 recalls

November 21, 2016· GE Healthcare, LLC

Recalled Item: RFX

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: ADVANTX LCV+

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: Prestilix

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: Innova 2000

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: Legacy

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: ADVANTX LCLP+

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: ADVANTX LCN+

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: SFX

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· GE Healthcare, LLC

Recalled Item: Prestige II

The Issue: GE Healthcare is conducting a recall due to

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

Class II — Potential Health HazardTerminated
November 21, 2016· Northgate Technologies, Inc.

Recalled Item: Insufflator

The Issue: Device could cause a patient overpressure situation without

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

Class II — Potential Health HazardTerminated
November 21, 2016· Smiths Medical ASD Inc.

Recalled Item: Acuvance¿2 Safety Catheter

The Issue: Smiths Medical became aware that three (3) lots

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

Class II — Potential Health HazardTerminated
November 21, 2016· Oculus Innovative Sciences, Inc.

Recalled Item: Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g

The Issue: Firm became aware that professional samples of Ceramax

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

Class II — Potential Health HazardTerminated
November 20, 2016· Shimadzu Medical Systems

Recalled Item: Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION

The Issue: Shimadzu Medical Systems is recalling the Shimadzu X-ray

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

Class II — Potential Health HazardTerminated
November 20, 2016· Shimadzu Medical Systems

Recalled Item: Shimadzu X-ray TV System

The Issue: Shimadzu Medical Systems is recalling Shimadzu X-ray TV

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

Class II — Potential Health HazardTerminated
November 18, 2016· Swissray Medical

Recalled Item: ddR Formula B X-ray System

The Issue: for bucky (the part that holds the

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

Class II — Potential Health HazardOngoing
November 18, 2016· Ohmeda Medical

Recalled Item: Giraffe Bedded Warmer

The Issue: Certain power cords could overheat. The affected power

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

Class II — Potential Health HazardTerminated
November 18, 2016· Ohmeda Medical

Recalled Item: Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an

The Issue: Certain power cords could overheat. The affected power

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

Class II — Potential Health HazardTerminated
November 18, 2016· Ohmeda Medical

Recalled Item: CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a...

The Issue: Certain power cords could overheat. The affected power

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

Class II — Potential Health HazardTerminated
November 18, 2016· Ohmeda Medical

Recalled Item: Giraffe Bedded Warmer

The Issue: Certain power cords could overheat. The affected power

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

Class II — Potential Health HazardTerminated
November 18, 2016· Ohmeda Medical

Recalled Item: Giraffe Bedded Warmer

The Issue: Certain power cords could overheat. The affected power

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

Class II — Potential Health HazardTerminated