Medline endoscopy convenience kits recalled for sterilization calibration issues
Check Medline endoscopy kits for sterilization defect
Medline Industries identified calibration problems in the equipment used to sterilize and package two models of endoscopy convenience kits. The kits were processed through sterilization cycles, but the equipment calibration issues may have affected whether the devices are truly sterile. No injuries have been reported.
- Check if your facility has Baptist Floyd Endo GI Kit (DYKE1455B) or GI Lab Other Endo Kit (DYKE1721)
- Match your kit's lot number against the FDA recall list
- Stop using affected kits and contact Medline for replacement or guidance
- Contact your Medline representative or the FDA if you have questions
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2026More Medline Industries, LP recalls
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- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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