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 7681–7700 of 38,428 recalls
Recalled Item: HAMILTON T1 Ventilator 1610060 161009 1610090 Is intended
The Issue: Due to a software anomaly after approximately 91
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON C3 Ventilator Is intended to provide positive
The Issue: Due to a software anomaly after approximately 91
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory
The Issue: Due to a software anomaly after approximately 91
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON C1 Ventilator 1610010 Is intended to provide
The Issue: Due to a software anomaly after approximately 91
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: A medical device correction is being issued for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA Spectrum Infusion Pump
The Issue: A medical device correction is being issued for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version...
The Issue: Devices with Option CP2 and initially programmed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella LD intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.0 intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP with SmartAssist intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simplexa Direct Amplification Disc Kit
The Issue: There is a potential for the direct amplification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 2.5 intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP intravascular micro axial blood pump
The Issue: There is a potential risk for unintentional interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1)
The Issue: Carryover from the Direct LDL-cholesterol assay on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2
The Issue: Dura regeneration matrix may have out-of-specification endotoxin levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Infinity Alignment Frame Distal Sub-Assembly
The Issue: The devices were manufactured with the pin sleeve
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X Magnetic Resonance (MR) system
The Issue: During installation of the SmokeDetector Interlock, a connecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 7700 Magnetic Resonance (MR) system
The Issue: During installation of the SmokeDetector Interlock, a connecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X Magnetic Resonance (MR) system
The Issue: The system operator is able to bypass the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.