Medline Lithotomy Pack surgical kits recalled over sterilization equipment calibration issues
What this means
Medline identified calibration problems with the equipment that sterilizes and packages certain Lithotomy Pack surgical kits. Although the kits went through sterilization cycles, the equipment issues may have affected whether the products are properly sterile. No injuries have been reported.
- Check if you have a Medline Lithotomy Pack (Model DYNJ83185 or DYNJ83185A) with one of the affected lot numbers listed in the recall notice
- Do not use affected kits for surgical procedures
- Contact Medline or your medical supplier for instructions on returning or replacing the 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-1398-2026More 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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