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 27421–27440 of 38,428 recalls

April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Arthroscope.

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Orthopedic manual

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. cannula

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Reamer.

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Plate

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Fastener

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Appliance

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Pin

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Passer.

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. Bit

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Biomet, Inc.

Recalled Item: Various trauma and sports medicine instruments and implants. guide

The Issue: Insufficient seal strength on sterile barrier packaging. The

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

Class II — Potential Health HazardTerminated
April 1, 2016· Medtronic

Recalled Item: Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS)

The Issue: Kangaroo Connect Feeding Pump Occlusion alarms fail to

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

Class II — Potential Health HazardTerminated
April 1, 2016· Applied Medical Resources Corp

Recalled Item: Direct Drive Clip Applier CA090

The Issue: Increased customer complaints indicating inconsistent clip application; may

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

Class II — Potential Health HazardTerminated
April 1, 2016· Medtronic

Recalled Item: Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US)

The Issue: Kangaroo Connect Feeding Pump Occlusion alarms fail to

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

Class II — Potential Health HazardTerminated
April 1, 2016· B Braun Medical Inc

Recalled Item: Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V

The Issue: leakage of conductivity sensors of the Dialog

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

Class I — Serious Health HazardTerminated
April 1, 2016· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: Smart CR Digital Computed Radiography System

The Issue: Reports of failure of the device's power supply

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

Class II — Potential Health HazardTerminated
April 1, 2016· B Braun Medical Inc

Recalled Item: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code

The Issue: leakage of conductivity sensors of the Dialog

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

Class I — Serious Health HazardTerminated
April 1, 2016· B Braun Medical Inc

Recalled Item: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The...

The Issue: leakage of conductivity sensors of the Dialog

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

Class I — Serious Health HazardTerminated
April 1, 2016· B Braun Medical Inc

Recalled Item: Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code

The Issue: leakage of conductivity sensors of the Dialog

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

Class I — Serious Health HazardTerminated
April 1, 2016· B Braun Medical Inc

Recalled Item: Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The

The Issue: leakage of conductivity sensors of the Dialog

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

Class I — Serious Health HazardTerminated