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 13141–13160 of 38,428 recalls
Recalled Item: DJO EMPOWR KNEE Femoral Sizer
The Issue: Incorrect assembly of a subcomponent by a vendor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System INFX-8000C
The Issue: The x-ray irradiation field may shift with respect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System INFX-8000F
The Issue: The x-ray irradiation field may shift with respect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of
The Issue: Incorrect lot of Substrate Reagent (TMB) may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System INFX-8000V
The Issue: The x-ray irradiation field may shift with respect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Label - ACUSON Sequoia *** Power Input: 100-240V~
The Issue: The ultrasound system averages the Mean Sac Diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Pack Infant Tubingset Pixie Flow 0
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous...
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous...
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B
The Issue: Products being recalled due to potentially elevated level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable cardioverter defibrillators (ICD) with cardiac resynchronization...
The Issue: A small percentage of implanted cardiac devices, from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coronavirus antigen detection test system - Product Usage: intended for
The Issue: Two lots of test strips failed QC testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR
The Issue: A small percentage of implanted cardiac devices, from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista HDLC - colorimetric method
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.