Medline surgical convenience kits recalled for sterilization equipment calibration issues
What this means
Medline Industries identified calibration problems with equipment used to sterilize and package two types of surgical convenience kits: Ancillary Pack-LF and Open Heart Anesthesia ICC-A. Although these products went through sterilization cycles, the equipment calibration issues may have affected whether the kits are fully sterile. This recall affects 551 units distributed nationwide.
- Check if you have Medline surgical kits matching the recalled model and lot numbers listed in the FDA notice
- Contact Medline Industries or the FDA with questions about your specific lot number
- Do not use recalled kits for procedures until you confirm your lot is not affected
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-1384-2026More 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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