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.
Showing 33561–33580 of 38,428 recalls
Recalled Item: enGen (TM) Laboratory Automation System configured with Data Innovations
The Issue: Software Anomaly: Ortho Clinical Diagnostics (OCD) has become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esmark Elastic Bandage (Sterile)
The Issue: This lot did not go through the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage BNP Test for the Beckman Coulter Access Family
The Issue: These lots may not recover within range when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: On-Board Imager - Exact Arm Elbow Motor Shaft (kVD
The Issue: Varian has identified a failure with the shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15FR Drain Kit
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FRAXEL DUAL 1550/1927 Laser System
The Issue: Obsolete versions of the Laser Treatment Settings card
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Saber 100ml Infection Control PVC Bulb with 150ml 3C System
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Saber 100ml Infection Control PVC Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7mm Drain Kit
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10mm Drain Kit
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator
The Issue: The recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.