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 16021–16040 of 38,428 recalls
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Central Venous Catheters are indicated for the assessment of hemodynamic
The Issue: Inability for the guidewire to pass through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075
The Issue: A mix-up of autosampler tube positions with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ulrich medical neon3 OCT spinal stabilization
The Issue: Due to a production error, the weld seam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Koios DS Breast <series 1.0>. The device is a software
The Issue: Affected software product versions were found during internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermage Face Tip 3.0
The Issue: Complaints of sparking of the tips of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integris Allura 9
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardio Vascular-Allura Centron
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroDiagnost Eleva
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniDiagnost Eleva System codes 708028 708027
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integris Allura 15 & 12
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost Eleva
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly G Integris H5000
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura CV20
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Exper FD Series. System codes 722003 722010 722022 722005
The Issue: A capacitor inside the converter of the Velara
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage:
The Issue: Due to a potential for sterile barrier breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WRIGHT EVOLVE Proline Head
The Issue: Two lots of EVOLVE Modular Radial Head could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.