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 11501–11520 of 38,428 recalls
Recalled Item: Aspiration Syringe Kit
The Issue: Syringe Kits labeled for distribution OUS were inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nimbus PainPro Ambulatory Infusion Pumps with software version v4
The Issue: An unreleased Version 4 Protocol Library was installed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model B35200 - Percept PC BrainSense Implantable Neurostimulator
The Issue: During cardioversion events, the Model B35200 Percept PC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Thyroxine (T4) ELISA
The Issue: Firm has identified two lots of product that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas u 601 urinalysis test system
The Issue: A potential risk for false negative nitrite results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model:
The Issue: VIPR (Valve Integrated Pressure Regulator) - battery rupture,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model:
The Issue: VIPR (Valve Integrated Pressure Regulator) - battery rupture,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
The Issue: VIPR (Valve Integrated Pressure Regulator) - battery rupture,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
The Issue: VIPR (Valve Integrated Pressure Regulator) - battery rupture,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz Udel Sterilization Tray Instructions for Use
The Issue: To ensure sterilization effectiveness, sterilization tray instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual
The Issue: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 28MM -4 LFIT V40 HEAD
The Issue: There is a potential for the outer white
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freelite Human Lambda Free Kit (for use on the SPAPLUS)
The Issue: Due to calibration curves producing a higher activity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual
The Issue: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 28MM -4 LFIT V40 HEAD
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Centricity Universal Viewer Zero Footprint Client
The Issue: There is a potential to display incomplete patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT...
The Issue: Due to, during stent graft deployment, the spindle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT...
The Issue: During stent graft deployment, the spindle may detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT...
The Issue: Due to, during stent graft deployment, the spindle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti-HBc IgM Controls
The Issue: Ortho Clinical Diagnostics confirmed a complaint that some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.