Medline LVAD driveline and central line trays recalled over sterilization calibration issue
What this means
Medline identified calibration problems with sterilization equipment used to process certain LVAD driveline and central line dressing change trays. These issues may have affected the sterility of the devices, even though they went through standard sterilization cycles. The recall affects specific lot numbers manufactured between 2020 and 2025.
- Check your inventory for the affected lot numbers listed in the recall (DM1035A, DM1035, or DT8670A)
- Stop using any trays matching the affected lot numbers
- Contact Medline or your supplier for instructions on return or replacement
- Notify your facility's infection control and clinical teams immediately
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-1411-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.