Medline LVAD driveline and central venous kits recalled for sterilization calibration issues
What this means
Medline has recalled certain LVAD driveline trays and central venous insertion kits due to calibration problems with sterilization equipment. These devices may not meet required sterility standards, even though they went through sterilization cycles. No injuries have been reported.
- Check if your facility has any of the affected lot numbers listed in the recall
- Do not use recalled kits; isolate them and contact your Medline representative
- Verify the model number and lot number on your packaging against the FDA recall notice
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-1402-2026More 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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