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 521–540 of 38,428 recalls
Recalled Item: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System
The Issue: Ongoing investigations identified additional instances of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy
The Issue: Ongoing investigations identified additional instances of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy
The Issue: Ongoing investigations identified additional instances of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for incomplete seal on header bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for incomplete seal on header bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carestation anesthesia system
The Issue: unexpected shutdown of Carestation 600 and 700
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for incomplete seal on header bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for incomplete seal on header bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Software version 5.10.1 and earlier contain anomalies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carestation anesthesia system
The Issue: unexpected shutdown of Carestation 600 and 700
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard
The Issue: for incomplete seal on header bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field
The Issue: unexpected shutdown of Carestation 600 and 700
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity ci-series System Control Module (SCM)
The Issue: Abbott Laboratories is recalling their Alinity ci-series System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InPen App
The Issue: When app is uninstalled and reinstalled, insulin pen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCISSORS
The Issue: The items may have weak packaging seals that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FORCEP
The Issue: The items may have weak packaging seals that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK
The Issue: Some products packaged for lot 818-111-7 may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Stryker CranialMask Tracker is a single-use device consisting of
The Issue: When the device is activated during surgery, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. CAMHB W/LHB
The Issue: Products may contain contamination, which may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.