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 32381–32400 of 38,428 recalls
Recalled Item: TRx Vertical Positioner
The Issue: Motion Concepts identified that there is a possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GYRUS ACMI
The Issue: Due to an anomaly in the packaging process,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Charnley PN Retract & Handle
The Issue: The small extraction peg of the Charnley Pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology" Hemo intended for complete physiological/hemodynamic...
The Issue: Software Error: The McKesson Cardiology Hemo calculation section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Justright Surgical
The Issue: JustRight Surgical is recalling specific lots of JustRight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Justright Surgical
The Issue: JustRight Surgical is recalling specific lots of JustRight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Ysio Systems with software version VC10 The Ysio enables
The Issue: Siemens discovered that an unlikely error may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm...
The Issue: The expiration date of the bar code on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Medical Patient Monitor is a Physiological
The Issue: The clinician did not realize the monitor was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m)
The Issue: Sterility of device is not assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012...
The Issue: Sterility of device is not assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard DuaLok Breast Lesion Localization Wire
The Issue: Bard Peripheral is recalling the Bard DuaLok Breast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part...
The Issue: Sterility of device is not assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EpiCenter Plus Microbiology Data Management System software version 6.20A
The Issue: The information in the EpiCenter interface translation tables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Convenience Kit with Accessories
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Convenience Kit with Accessories
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Convenience Kit with Accessories
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Convenience Kit with Accessories
The Issue: NMI was notified by the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.