Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 9 months ago
Vantive Us Healthcare LLC Oxiris SET, Product Code 112016 recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Vantive Us Healthcare LLC Prismaflex ST100 SET US, Product Code 107636US recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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Class II · 9 months ago
Focalyx Fusion recall: Software device that is an accessory for image-guided interventional
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Vantive Us Healthcare LLC Primsaflex M100 SET, Product Code 106697 recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class I · 9 months ago
Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class I · 9 months ago
Boston Scientific Corporation HOT AXIOS Stent and Electrocautery-Enhanced Delivery recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Fujirebio Diagnostics, Inc. Product Name: Lumipulse G pTau 217 Plasma Calibrators recall: Customers may experience inaccurate test results by observing a higher
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low…
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Class II · 9 months ago
Etac A/S Brand Name: Molift Product Name: Molift Mover 205 Model/ recall: A customer experienced that during assembly and load testing of the device
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. Exploro Highly Sensitive Male Fertility / recall: Test strips and other tests including for near-patient testing
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S…
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Class II · 9 months ago
Biomerieux Inc VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B o recall: Potential risk of Quality Control failures and/or false resistant antibiotic
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae…
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Class II · 9 months ago
Changchun Wancheng Bio-Electron Co., Ltd. Male Fertility Sperm Test for Home Use recall: Test strips and other tests including for near-patient testing
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Single Use 3-Lumen Sphincterotome V recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.
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Class II · 9 months ago
Etac A/S Brand Name: Molift Product Name: Molift 4-point sling bars Model/ recall: A customer experienced that during assembly and load testing of the device
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation…
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Class II · 9 months ago
Fujirebio Diagnostics, Inc. Product Name: Lumipulse pTau 217 Plasma Controls Model/ recall: Customers may experience inaccurate test results by observing a higher
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low…
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Class II · 9 months ago
Olympus Corporation of the Americas Product Name: Disposable Triple Lumen recall: Devices which did not undergo thermoforming could deform and lose performance
Devices which did not undergo thermoforming could deform and lose performance.