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 1081–1100 of 38,428 recalls
Recalled Item: CARESCAPE ONE
The Issue: loss of monitoring on affected monitors when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portrait VSM Model nos. 6660000-666 Monitor
The Issue: loss of monitoring on affected monitors when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient
The Issue: loss of monitoring on affected monitors when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carescape B450
The Issue: loss of monitoring on affected monitors when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN Disposable Perforator 11mm. Cranial Perforator.
The Issue: Expansion of recall of size 14 mm Codman
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN Disposable Perforator 9mm. Cranial Perforator.
The Issue: Expansion of recall of size 14 mm Codman
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medistim MiraQ System Product Name: Medistim MiraQ System
The Issue: Printer Support Module (PSM) may be subject to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOW PROF LCKNG SCREW
The Issue: Although the etched length on the screw is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOW PROF LCKNG SCREW
The Issue: Although the etched length on the screw is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cold Form Wrap: Back
The Issue: The IFU (Information for Use) on the wrap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm...
The Issue: A manufacturing issue could lead to a malformed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm...
The Issue: A manufacturing issue could lead to a malformed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model: Incisive CT for Brazil SKD
The Issue: Issue 1: The potential for unintentional continued gantry/couch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model: CT 5300
The Issue: Issue 1: The potential for unintentional continued gantry/couch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA Ballast Distal Access Platform Product Name: Mega
The Issue: Due to an identified manufacturing defect involving coating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model: Incisive CT
The Issue: Issue 1: The potential for unintentional continued gantry/couch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artegraft¿ Collagen Vascular Graft
The Issue: The device was incorrectly packed in the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC FOCUS Shears + Adaptive Tissue Technology
The Issue: Due to manufacturing issue, reprocessed shears, may become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.