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 25401–25420 of 38,428 recalls
Recalled Item: Maquet Express Dry Seal Suction Chest Drain
The Issue: Chest drains manual vent valve located at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT
The Issue: The intended use listed in the English and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT
The Issue: During a retrospective review of production documentation it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optilite IgG4 Kit Product Code: LK009.OPT.A
The Issue: A change to the lower end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation
The Issue: Cross profile for Varian 60 degree wedge shows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX Cardiovascular The IMPAX CV Reporting module consists of a
The Issue: A customer experienced when using IMPAX CV Reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAKO RIO THA Application User Guides
The Issue: Five (5) AFMEA Risk Control Measures are missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Keyspan High-High Speed USB to Serial Adapter Product Usage: The
The Issue: Power outages causes reporting software to shutdown
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannulated Drill bit 2.0mm and 2.6 mm
The Issue: The product is being recalled due to incidence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agfa Healthcare NX 3.0.8950 Imaging Processing Software
The Issue: A customer reported that when using an NX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/IMMULITE 1000 Systems
The Issue: Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/IMMULITE 1000 Systems
The Issue: Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Program Update Package AutoDELFIA¿ 3.0
The Issue: AutoDELFIA System with Version 3.0 Software: Potential plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELFIA¿ PC with V3.0 Software
The Issue: AutoDELFIA System with Version 3.0 Software: Potential plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoDELFIA¿ Plate Processor
The Issue: AutoDELFIA System with Version 3.0 Software: Potential plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008K@home Series : Hemodialysis System
The Issue: When the UF Rate, Goal or Time is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008K2 Series : Hemodialysis System
The Issue: When the UF Rate, Goal or Time is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008T Series Hemodialysis System
The Issue: When the UF Rate, Goal or Time is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200
The Issue: Beckman Coulter initiated a design change to update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008K Series : Hemodialysis System
The Issue: When the UF Rate, Goal or Time is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.