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 38101–38120 of 38,428 recalls
Recalled Item: Tip Cover Accessory
The Issue: Clarification of existing labeling and related cautions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Marathon Flow Directed Micro Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraFlow HPC Flow Directed Micro Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentron Clinical Metrex Research
The Issue: The firm initiated the recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgeon Console. Intended to assist in the
The Issue: Clarification of existing labeling information and operating procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flush Port (used in almost all da Vinci instruments) Assists
The Issue: Clarification of existing labeling information and operating procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannula 8MM Regular. Provides the means of introduction and placement
The Issue: Clarification of existing labeling information and operating procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: .***ANSPACH***Sterile. ***QTY: 1
The Issue: Anspach Effort, Inc. Palm Beach Gardens, FL is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics SealFlex Single Port Ribbed Mask (Infant). For general use
The Issue: The mask inside the package has been identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
The Issue: Recall was initiated due to the observation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fuso Analyzer 300F
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT1 Abaxis Analyzer
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT1 Abaxis Analyzer
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Military Kit Portable Clinical Analyzer
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-Stat Portable Clinical Analyzer
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iStat1 Analyzer Abbott Point of Care
The Issue: Some i-Stat Analyzers become uncomfortably hot to touch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Animas Vibe Insulin Infusion Pump. This product is indicated for
The Issue: Calibration factors in the pump overwritten during a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray
The Issue: During a Field Test (a customer external evaluation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.