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 21421–21440 of 38,428 recalls
Recalled Item: Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
The Issue: The Discovery IGS and Innova IGS systems may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem VELOCITY Automated Urine Chemistry System
The Issue: The Strip Provider Modules (SPM) on some of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Connecting Tube - Female to Male Luer Lock
The Issue: Cap-adapter assembly of the device may potentially not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Segmental System Proximal Femoral Component 38mm Offset
The Issue: There is a potential for debris in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore Radiology 728244
The Issue: A problem has been detected in the X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenuity Core 728321
The Issue: A problem has been detected in the X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core128 728323
The Issue: A problem has been detected in the X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT 882442
The Issue: A problem has been detected in the X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core128/Elite China 728324
The Issue: A problem has been detected in the X-Ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Radiation Therapy Treatment Planning System
The Issue: The dose calculation accuracy may in some situations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Acute Care System (lACS) Monitoring Solution
The Issue: Software anomaly resulting in the loss of patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentle Threads
The Issue: Specific lots of the device were overexposed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentle Threads
The Issue: Specific lots of the device were overexposed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentle Threads
The Issue: Specific lots of the device were overexposed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentle Threads
The Issue: Specific lots of the device were overexposed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.