Medline Dental Pack (DYNDA3003) recalled for sterilization equipment calibration issues
What this means
Medline Industries identified calibration problems with equipment used to sterilize and package certain Dental Pack kits (Model DYNDA3003). While the products went through sterilization cycles, the calibration issues may have affected whether the packages remain sterile. This recall affects specific lot numbers manufactured between 2022 and 2024.
- Find the lot number on your Medline Dental Pack DYNDA3003 kit
- Compare it to the 12 affected lot numbers listed in the FDA recall notice
- If your kit matches, stop using it and contact Medline or your supplier
- Ask your supplier or Medline how to return or replace affected kits
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-1393-2026More 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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