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 32681–32700 of 38,428 recalls
Recalled Item: VITROS 5600 Integrated System --- For use in the in vitro quantitative
The Issue: Ortho Clinical Diagnostics has identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excella II Standard Pedicle Screw
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERO Linear Accelerator System
The Issue: Software Anomaly: If a user changes the calendar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)
The Issue: Positive result in the Internal negative control well
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/...
The Issue: Unsealed pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin
The Issue: BD has initiated the recall of its Vacutainer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelePACS software versions 3-8-1 to 4-9-1
The Issue: In specific situation a partially truncated file may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve only with SIPHONGUARD¿ Device
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve Only
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve with SIPHONGUARD¿
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve with SIPHONGUARD¿ Device
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve with Catheter and Accessories
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve with SIPHONGUARD¿ Device
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In Line Valve with Unitized Catheter and Accessories
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories
The Issue: To clarify the CODMAN CERTAS Valve virtual off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ Infusion System is designed to meet the
The Issue: One lot of alarm assemblies used in Plum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ Infusion System is designed to meet the
The Issue: One lot of alarm assemblies used in Plum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ Infusion System is designed to meet the
The Issue: One lot of alarm assemblies used in Plum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ Infusion System is designed to meet the
The Issue: One lot of alarm assemblies used in Plum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Plum A+ Infusion System is designed to meet the
The Issue: One lot of alarm assemblies used in Plum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.