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 6701–6720 of 38,428 recalls
Recalled Item: Medline Kits
The Issue: Medline Industries, LP is recalling certain kits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Kits
The Issue: Medline Industries, LP is recalling certain kits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The INFX-8000F is designed to take advantage of the latest
The Issue: VAREX changed the manufacturing of the internal board,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The device is an X-ray system that is capable of
The Issue: VAREX changed the manufacturing of the internal board,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian 4 Glucose Sensor
The Issue: Some sensors may have a glucose oxidase (GOX)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoClean 2
The Issue: New User Manual with additional instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoClean 3
The Issue: New User Manual with additional instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Landauer microSTARii reader
The Issue: MicroSTARii readers may be contributing to the nanodot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set
The Issue: There is to an increase in complaints related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensica Urine Output System
The Issue: BD (C.R. Bard) has received user complaints reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX Spectranetics
The Issue: Incorrect product labeling. Exterior product box label does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Recanalization System
The Issue: Recanalization systems may be in a manufacturing mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide
The Issue: CARDIOHELP-i System was not properly tested to measure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibration Serum Level 3. CAL 3
The Issue: There have been transcription errors on the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORI REAL INTELLIGENCE Robotic Drill
The Issue: Possibility that the user is unable to resolve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II
The Issue: Medtronic recently identified that if the SynchroMed II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II
The Issue: Medtronic recently identified that if the SynchroMed II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS
The Issue: Identification label on affected hookups could become illegible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venous probe connection cable ( and 701048804) used with
The Issue: Firm received complaints of breaks in the insulation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.