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 34601–34620 of 38,428 recalls
Recalled Item: The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on
The Issue: Nanosphere has received several reports relating to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative
The Issue: Nanosphere has received several reports relating to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)
The Issue: Nanosphere has received several reports relating to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed
The Issue: Nanosphere has received several reports relating to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250
The Issue: Ortho Clinical Diagnostics issued a product correction notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova StatStrip/StatSensor Hospital Blood Glucose Meter
The Issue: Revised Battery Instructions for Removal and Expiration Date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mizuho Sugita Titanium Standard Aneurysm Clip II
The Issue: Specific item numbers form Lots 27-J and 29-J
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mizuho Sugita Titanium Standard Aneurysm Clip II
The Issue: Specific item numbers form Lots 27-J and 29-J
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juggerknotless Drill Bit
The Issue: Investigation identified that the design of the drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
The Issue: NT2000iX software shipped with the international setting turned
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems.
The Issue: There is an issue with the Manual Film
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral
The Issue: A labeling inconsistency was discovered in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS CA 125 II Calibrators For use in the calibration
The Issue: Ortho Clinical Diagnostics issued a Product Correction Notification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Transradial Artery Access products Arrow Transradial Artery Access...
The Issue: There is a risk that the introducer needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is
The Issue: A labeling correction was initiated related to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinica Anterior Lumbar Plate (ALP) system
The Issue: Zimmer Spine, Inc. is initiating a correction regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Track System with enGen Select v5.0 with autoverification enabled
The Issue: Ortho Clinical Diagnostics issued an Urgent Product Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5
The Issue: Ortho Clinical Diagnostics issued an Urgent Product Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder
The Issue: Complaints were received which described the SynFix LR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on
The Issue: In systems with version 10.4 software Initial Drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.