95,064 total recalls in our database
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Boston Scientific
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
VANTIVE US HEALTHCARE
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Vortex Surgical
XXX
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Vortex Surgical
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
VANTIVE US HEALTHCARE
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
VANTIVE US HEALTHCARE
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Siemens Medical Solutions USA
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Encore Medical
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Changchun Wancheng Bio-Electron Co.
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. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.
Siemens Medical Solutions USA
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Boston Scientific
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of the Americas
Devices which did not undergo thermoforming could deform and lose performance.