All recalls8,501 total
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Devices which did not undergo thermoforming could deform and lose performance.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Devices which did not undergo thermoforming could deform and lose performance.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Devices which did not undergo thermoforming could deform and lose performance.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Devices which did not undergo thermoforming could deform and lose performance.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Potential undeclared allergen ingredient (Wheat)
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Product contains milk, which is undeclared in the ingredient statement.
Product contains milk, which is undeclared in the ingredient statement.
Product contains milk, which is undeclared in the ingredient statement.
Contains undeclared sesame
Potential undeclared allergen ingredient (Wheat)
cGMP deviations.
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
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.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
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.
Presence of Particulate Matter.
Due a design issue where the navigated array connection geometry is incorrect.
Tyvek bag seal issue which may compromise sterility of the kit.
Due a design issue where the navigated array connection geometry is incorrect.