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 21961–21980 of 38,428 recalls
Recalled Item: InControl Insulin Syringes
The Issue: Insulin syringe retail packages incorrectly labeled as "Short
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restoris MCK Onlay Insert Extractor.
The Issue: hinge pin disassociation from the Mako Onlay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides
The Issue: Inaccurrate flow readings. Depending on the degree of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SwishPlus Implant Intended for use in support for fixed bridgework.
The Issue: The extender that is packaged with the SwishTapered"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SwishTapered Implant Intended for use in support for fixed bridgework.
The Issue: The extender that is packaged with the SwishTapered"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoMate 1200 Catalog Number ODL25120
The Issue: Belts on the x-axis (and on the y-axis,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinal Jaxx Interbody Fusion Device
The Issue: The implant size is incorrectly etched on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluid Management Convenience Kits (Angioplasty Kits) intended to be used
The Issue: NAMIC Fluid Management Convenience Kits contains a Fluid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoMate 2550 "High Speed" Catalog Number ODL25255
The Issue: A misaligned pipette tip sensor poses the remote
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
The Issue: breakage of the endoscope s insertion tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uretero-reno fiberscope URF-P6RP6
The Issue: Breakage of the endoscope's insertion tube bending section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uretero-reno fiberscope URF-P6
The Issue: Breakage of the endoscope's insertion tube bending section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare Xhibit Telemetry Receiver
The Issue: Spacelabs has received multiple complaints reporting telemetry beds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic AFFINITY NT
The Issue: sterile barrier breach in the pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic TRILLIUM AFFINITY NT
The Issue: sterile barrier breach in the pouch of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK
The Issue: The affected products were inadvertently packaged with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2)
The Issue: A manufacturing defect on the amplifier board of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer
The Issue: A manufacturing defect on the amplifier board of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol...
The Issue: Product is not meeting specification for traceability to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MYPICC Kit
The Issue: One of the cases of product might not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.