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 16941–16960 of 38,428 recalls
Recalled Item: Karl Storz NEURO-FIBERSCOPE
The Issue: During a complaint investigation it was determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE
The Issue: During a complaint investigation it was determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz
The Issue: During a complaint investigation it was determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Volume Cartridge IFU (SKU CAR-125-B) used with the following
The Issue: There is a potential patient health risk while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AD-TECH Drill Sleeve Guides
The Issue: The inner diameter of the drill sleeve guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Control Panel 60-02-15: LivaNova SCP Pump Control Panel.
The Issue: The SCP control Panel rotary knob used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Control Panel 60-02-50: LivaNova SCP Pump Control Panel
The Issue: The SCP control Panel rotary knob used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Positron Emission Tomograpy and Computed Tomography System
The Issue: sporadic software bugs in R001.3.0.0.750505 software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pharos Excimer Laser
The Issue: At doses of less than 100 mJ, in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The
The Issue: Remote Antenna Cable Used with Philips MX4O Monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco Radiation Treatment Planning System (RTP) System
The Issue: Monaco is displaying the Anatomy and Beam shift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concerto & Basic Shower Trolly
The Issue: The firm has become aware that any of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy
The Issue: Sentiva generators may reset and become disabled within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CentriMag Acute Circulatory Support System Motor
The Issue: Reports have been received of the CentriMag Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Hip Replacement System
The Issue: Two femoral stems, sizes 13 and 15, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Hip Replacement System
The Issue: Two femoral stems, sizes 13 and 15, were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a
The Issue: Based on an internal incident report, Getinge/Intervascular SAS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEZANNE II TLIF Bullet-Tip Cage
The Issue: Reports received of the device fracturing during insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEZANNE II TLIF Bullet-Tip Cage
The Issue: Reports received of the device fracturing during insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEZANNE II TLIF Bullet-Tip Cage
The Issue: Reports received of the device fracturing during insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.