FDA (Devices) recall action 98642
The FDA (Devices) publishes a recall like this one as 42 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 42 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling Basic Nerve Block Trays due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the devices.
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
Medline Industries is recalling multiple Convenience Kits nationwide because sterilization equipment calibration issues may have compromised the sterility assurance level of the products, despite exposure to validated sterilization cycles.
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Medline is recalling two models of Convenience Kits because calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.
Medline is recalling five models of arthroscopy convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Medline is recalling Convenience Kits (Model DYNJ50806L) because equipment calibration issues may have affected the sterility assurance level of the devices. The products were exposed to sterilization and packaging cycles but the calibration problems could impact their sterility.
Medline Industries is recalling three models of medical trays due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects LVAD Driveline Trays and Central Line Dressing Change Trays distributed nationwide.
Medline Industries is recalling multiple Convenience Kit medical devices due to calibration issues in sterilization and packaging equipment that may affect sterility assurance. The devices were distributed nationwide.
Medline Industries is recalling 26 models of medical convenience kits used in clinical settings because equipment calibration issues may have compromised sterility assurance during sterilization and packaging.
Medline Industries is recalling multiple convenience kits used in surgical and biopsy procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The recall affects 4,064 units distributed nationwide.
Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
Medline is recalling three models of medical convenience kits (central line, LVAD driveline, and surgical oncology) distributed nationwide due to calibration issues in sterilization equipment that may have reduced sterility assurance.
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.
Medline is recalling Convenience Kits (PPE Kit, Model DYK1011945P) due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. The product was distributed nationwide.
Medline Industries is recalling over 7,700 surgical convenience kits due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Medline Industries is recalling 114,778 surgical convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products. No illnesses or injuries have been reported.
Medline Industries is recalling multiple convenience kits due to calibration issues with sterilization and packaging equipment that may compromise sterility assurance. Approximately 5,497 units were affected and distributed nationwide.
Medline is recalling Admit Kits (Model DYKA1343A) due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the devices.
Medline Industries is recalling eight models of Convenience Kits due to calibration issues with sterilization equipment that may have affected the sterility assurance level of the devices.
Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.
Medline is recalling certain Dental Pack and Surgical Pack convenience kits due to calibration issues with sterilization equipment that may affect sterility assurance. Approximately 3,508 units were distributed nationwide.
Medline Industries is recalling approximately 15,806 surgical device kits used in gynecology, urology, and thoracic procedures. Calibration issues with sterilization and packaging equipment may have compromised the sterility assurance level of the devices.