Medline surgical and biopsy kits recalled over sterilization equipment calibration issues
What this means
Medline has recalled multiple surgical and biopsy convenience kits due to calibration problems with sterilization equipment. While the kits went through standard sterilization cycles, the equipment calibration issues may have affected whether the kits are truly sterile. No injuries have been reported.
- Check if your facility has any Medline convenience kits with the affected model and lot numbers listed in the recall.
- Do not use kits matching the recalled lots until you receive instructions from Medline or your supplier.
- Contact Medline or your medical supplier for replacement kits or further guidance.
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-1392-2026More 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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