Medline tracheostomy convenience kits recalled for potential sterilization issues
Check Medline tracheostomy kits for recall
Medline has recalled certain tracheostomy convenience kits and Trach Tote bags due to calibration problems with the sterilization equipment used during manufacturing. While the products went through sterilization cycles, the calibration issues may have affected their sterility. No injuries have been reported.
- Check if you have a recalled kit by matching the model number (DYKMBNDL55, DYKMBNDL55A, or DYNJ85691) and lot number to the FDA list
- Do not use recalled products; contact Medline or your healthcare provider for guidance on replacement or disposal
- If you have used a recalled kit, consult your healthcare provider about any concerns
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-1385-2026More Medline Industries, LP recalls
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- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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