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 34681–34700 of 38,428 recalls
Recalled Item: SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP
The Issue: Baxter Healthcare Corporation is recalling the LCD display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems
The Issue: Beckman Coulter is initiating a recall for UniCel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S5 Heart-lung machine
The Issue: Sorin Group is recalling certain models of S5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER LH 750 and LH 780 Analyzers. The COULTER LH
The Issue: The check valves may fail on the Coulter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System
The Issue: A limitation in interoperability between the Philips Xper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System
The Issue: A limitation in interoperability between the Philips Xper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ComboMap Intravascular Flow and Pressure System
The Issue: A limitation in interoperability between the Philips Xper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExciTE F DSC Soft touch Single Dose
The Issue: Ivoclar Vivadent, Inc. is recalling a lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baylis Medical TorFlex Transseptal Guiding Sheath
The Issue: The TorFlex Transseptal Guiding Sheath Kits are being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Spinal Tray with Drugs 25g Whitacre
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Saddleblock Tray with Drugs 25g Quincke
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Spinal Tray with Drugs 25g Whitacre
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer)
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Spinal Tray with Drugs 25g Whitacre
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Spinal Tray with Drugs 22g/25g Quincke
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Saddleblock Tray with Drugs 26g Quincke
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex¿ Regional Anesthesia Tray with Drugs
The Issue: Visual particulate in the glass ampules of 5%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name:
The Issue: Alere San Diego, Inc. initiated a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDRAD¿ Stellant CT Injector System with Certegra Workstation
The Issue: The root cause investigation showed that the under-volume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.