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 32281–32300 of 38,428 recalls

September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific Specimen Transportation System. Product Usage: 10%...

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Protocol 10% NBF Product Usage: 10% NBF is used to

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 17, 2014· Richard-Allan Scientific Company

Recalled Item: Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF

The Issue: The affected lots could have NBF concentrations that

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

Class I — Serious Health HazardTerminated
September 16, 2014· Baxter Healthcare Corp

Recalled Item: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile

The Issue: Particulate matter found inside the fluid path

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

Class I — Serious Health HazardTerminated
September 16, 2014· Baxter Healthcare Corp

Recalled Item: Baxter 2B8011 Empty INTRA VIA Container with PVC Ports

The Issue: Particulate matter found inside the fluid path

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

Class I — Serious Health HazardTerminated
September 16, 2014· Bio-Detek, Inc.

Recalled Item: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires

The Issue: Product sterility is not assured

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

Class II — Potential Health HazardTerminated
September 16, 2014· Bio-Detek, Inc.

Recalled Item: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m)

The Issue: Product sterility is not assured

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

Class II — Potential Health HazardTerminated
September 16, 2014· Bio-Detek, Inc.

Recalled Item: ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012...

The Issue: Product sterility is not assured

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

Class II — Potential Health HazardTerminated
September 16, 2014· Bio-Detek, Inc.

Recalled Item: ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number:...

The Issue: Product sterility is not assured

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

Class II — Potential Health HazardTerminated
September 15, 2014· GE OEC Medical Systems, Inc

Recalled Item: GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used

The Issue: mA Accuracy may exceed the design and labeling

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

Class II — Potential Health HazardTerminated
September 15, 2014· GE OEC Medical Systems, Inc

Recalled Item: GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used

The Issue: mA Accuracy may exceed the design and labeling

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

Class II — Potential Health HazardTerminated
September 15, 2014· Codman & Shurtleff, Inc.

Recalled Item: Codman Lumbar Drainage Catheter Kit II with EDS 3 (External

The Issue: tubing within the system that drains CSF may

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

Class II — Potential Health HazardTerminated
September 15, 2014· Arrow International Inc

Recalled Item: ASK-05501-AFH1

The Issue: Arrow International, Inc. is notifying customers that lot

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

Class II — Potential Health HazardTerminated
September 15, 2014· Codman & Shurtleff, Inc.

Recalled Item: Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage

The Issue: tubing within the system that drains CSF may

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

Class II — Potential Health HazardTerminated
September 15, 2014· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur¿ Systems HBc Total (HBcT)

The Issue: Increased imprecision and positive bias is observed with

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

Class II — Potential Health HazardTerminated
September 15, 2014· Primus Medical LLC

Recalled Item: AC Powered adjustable bed frame. AC powered adjustable bed frame

The Issue: Firm received several complaints that the head deck

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

Class II — Potential Health HazardTerminated
September 15, 2014· Codman & Shurtleff, Inc.

Recalled Item: Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage

The Issue: tubing within the system that drains CSF may

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

Class II — Potential Health HazardTerminated