Medline PPE Convenience Kit (Model DYK1011945P) recalled for potential sterility issues
What this means
Medline Industries identified calibration problems with equipment used to sterilize and package certain PPE Convenience Kits. Although the products went through sterilization, the equipment issues may have affected how well the sterility protection worked. Multiple lot numbers from 2021 through 2025 are involved.
- Check if you have a Medline PPE Kit Model DYK1011945P
- Verify the lot number on your kit against the FDA recall list
- Stop using any affected kits and contact Medline or your supplier for instructions
- If you have questions, call Medline customer service or check the FDA website for the full lot number list
The agency's original wording
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-1408-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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