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 22401–22420 of 38,428 recalls
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Particulate found on the Curlin spike
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD(R) CRITICORE(R) MONITOR
The Issue: BMD has identified that some lots of CritiCore(R)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128
The Issue: Philips has identified that certain fasteners cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64
The Issue: Philips has identified that certain fasteners cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Intended to produce images of the head and
The Issue: Philips has identified that certain fasteners cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core
The Issue: Philips has identified that certain fasteners cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10g/15mm (15/2) iVAS System Kit
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. 11g/10mm iVAS System Kit
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press.
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press.
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intramedullary Brush Standard O.D. 14 mm
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCD Kit: Long 90
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11g Verteport Cement Cannula (18/pkg)
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Femoral Canal Pressurizer without Hub
The Issue: Lack of sterility assurance as bioburden levels were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator
The Issue: An increase in the number of failed calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.