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 25641–25660 of 38,428 recalls
Recalled Item: Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System-
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IWS Infant Warmer System-Infant radiant warmers provide infrared heat
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Exam Light The Exam Light illuminates body surfaces and
The Issue: Certain power cords could overheat. The affected power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical...
The Issue: Labeled as a 48mm Cortical Screw but measuring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System
The Issue: There's a potential for liquid penetration into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay
The Issue: Siemens Healthcare Diagnostics has confirmed that the IMMULITE/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay
The Issue: Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS-651
The Issue: Incorrect priming volume is printed on the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK Visistat 35W
The Issue: Sterility Deficiency: The packages are not sealed properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Add-On Bag Access Device
The Issue: CareFusion is recalling the SmartSite Add-On Bag Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROFEMUR(R) R RASP HANDLE
The Issue: The recall is being initiated because all broach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UltraSeal XT Plus Clear . The package contains 4x 1.2
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco TRP System The Monaco system is used to make
The Issue: Contours are not handled correctly if the CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (R) DEAD BLOW MALLET
The Issue: The firm received complaints of cracks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
The Issue: A DELFIA hFSH kit lot failed real time
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Fusion" Oxygenator with Integrated Arterial Filter
The Issue: Medtronic is initiating a voluntary product recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is
The Issue: The LightCycler¿ 480 algorithm used for the LightMix¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.