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 22981–23000 of 38,428 recalls
Recalled Item: EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing
The Issue: The CO/CO2 sensor cable harness may have lower
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReWalk Personal 6.0. Catalog number: 50-20-0004.
The Issue: Firm received complaints for ReWalk Personal 6.0 of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ablatherm(R) Integrated Imaging
The Issue: The US FDA has requested the optional energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS DEERFIELD IMAGING
The Issue: incorrect thread on thumbscrews
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniPerc(R) Adjustable Flange Tracheostomy Tube kit
The Issue: Smiths Medical became aware that one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Unity software
The Issue: The software is not identifying the patient as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
The Issue: The ACTH in Immunoassay Premium and Premium Plus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
The Issue: The ACTH in Immunoassay Premium and Premium Plus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring
The Issue: Intermittent communication between the host system and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norian Drillable Inject
The Issue: The contract supplier notified DePuy Synthes on June
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of
The Issue: The NS357R Vega PS Tibia Trial/Preparation Plateau size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norian Drillable Inject
The Issue: The contract supplier notified DePuy Synthes on June
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transfer/Gait Belt
The Issue: The locking mechanism on the belt may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transfer/Gait Belt
The Issue: The locking mechanism on the belt may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra Brachy 4.5 radiation therapy software The firm name on
The Issue: Incorrect source step size may occur in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Arm Support
The Issue: Rigid Arm Supports (PN: 106015 and 106047), which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Arm Support
The Issue: Rigid Arm Supports (PN: 106015 and 106047), which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Synchromed II Model 8637 supplied in 20mL and 40
The Issue: Medtronic implemented a final design change intended to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module model 8100 manufactured between November 2011 and March 2012
The Issue: The recalling firm has received reports of increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Cardiac Control CQ5053
The Issue: Randox has confirmed that Troponin T and Troponin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.