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 27961–27980 of 38,428 recalls
Recalled Item: Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack ()
The Issue: ADVIA Centaur Systems Calibrator E Lot 42 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (Stryker) AccuPlace Round Level Needle Guide
The Issue: During an evaluation of the product packaging, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion Tubing Pack
The Issue: Medtronic is notifying customers who have or may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (Stryker) AccuPlace Straight Level Needle Guide
The Issue: During an evaluation of the product packaging, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide
The Issue: During an evaluation of the product packaging, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide
The Issue: During an evaluation of the product packaging, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evita Infinity V500 Ventilator
The Issue: The battery capacity of the optional PS500 power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC/CVC Secure Dressing Change kit
The Issue: Misbranding; Due to the presence of CHG in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virage OCT Spinal Fixation System. Intended to promote fusion of
The Issue: Zimmer Biomet Spine is initiating a Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S3 MedSurg Bed
The Issue: CPU board failures cause fowler (backrest) electronic controls
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volk G-4 Small Ring
The Issue: The firm discovered that the incorrect lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QFT TB Antigen Tube. QIAGEN Sciences
The Issue: for obtaining a false positive result due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Auto Endo5 Hem-o-lok Automatic Clip Applier
The Issue: The clip in the applier may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellex Medical Fixed eye Safety filters Model Integre S LP5532.
The Issue: The Firm discovered that there is a design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadSuite software. The firm name on the label is Merge Healthcare
The Issue: for RadSuite AV viewer to skip image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OfficePACS software. The firm name on the label is Merge Healthcare
The Issue: data loss occurs as a result of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge FlexConnect software
The Issue: Communication protocols interfacing with the affected software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADstream software. The firm name on the label is Merge Healthcare
The Issue: The software was not presenting the PURE filter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Enterprise Archive. The firm name on the label is Merge Healthcare
The Issue: Interventional Radiology (IR) images are stored as JPEG2k
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. Product Usage: Merge Cardio is an integrated
The Issue: Patient information in the header is only found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.