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 29401–29420 of 38,428 recalls
Recalled Item: Fenestrated Bipolar Forceps
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maryland Dissector
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Driver
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curved Needle Driver
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maryland Bipolar Forceps
The Issue: In certain circumstances involving select da Vinci Si
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI 500 Blood Parameter Monitoring System. Provides continuous
The Issue: Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a
The Issue: Software defect that impacts image alignment when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBC Vascular Loop Catalog Number CH111
The Issue: It was discovered that the heat seal placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBC Suction Wand Catalog Number 1990S Product Usage: The IBC
The Issue: It was discovered that the heat seal placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBC Aortic Punch Catalog Numbers APM40
The Issue: It was discovered that the heat seal placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuro Combo Set Case The cases hold surgical instrumentation in
The Issue: The lids on implant caddies within P/N 17-5000
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thinflap System Case The cases hold surgical instrumentation in place
The Issue: The lids on implant caddies within P/N 17-5000
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF
The Issue: SynCardia Systems, Inc. is recalling Freedom Drivers due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Triple Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mahurkar Elite Acute Dual Lumen Catheter Tray
The Issue: Sterility may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7 Hole VL Gridlock Fibula Plate
The Issue: The affected parts subject to the recall are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.