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 20101–20120 of 38,428 recalls
Recalled Item: CAPNOSTREAM 20P (US) N W/PRINTER - ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (US) N - ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 (US) N
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 N W/PRINTER CYVITAL
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (US) N
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (INTL) N - ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 M W/PRINTER CYVITAL
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOLOGIX AFX/AFX2
The Issue: Endologix is notifying physicians of patient tailored surveillance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 (INTL) M W/PRINTER
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 (US) M W/PRINTER
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (US) N - ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20 (US) N
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 Coulter Cellular Analysis System
The Issue: Complaints received of sporadic erroneously elevated platelet results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 600 Coulter Cellular Analysis System
The Issue: Complaints received of sporadic erroneously elevated platelet results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 900 Coulter Cellular Analysis System
The Issue: Complaints received of sporadic erroneously elevated platelet results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitality¿ Spinal Fixation System.Spinal Intervertebral Body
The Issue: The Vitality Shear-off Set Screw is not threading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system...
The Issue: The Vitality Shear-off Set Screw is not threading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitality¿ Spinal Fixation System. Spinal Interlaminal
The Issue: The Vitality Shear-off Set Screw is not threading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail Tibial Nail - Yellow 8.3mm
The Issue: The item is labeled as an 8.3mm, but
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.