Medline triple lumen insertion kit recalled for potential sterilization failure
What this means
Medline identified calibration problems with equipment used to sterilize and package their triple lumen insertion kits (Model DYNDM1031A). While the kits went through sterilization, the calibration issues may have affected whether they are truly sterile. This affects 15 units with lot number 23EBM150.
- Stop using the triple lumen insertion kit (Model DYNDM1031A, Lot 23EBM150) immediately
- Contact Medline if you have this product to arrange return or replacement
- Do not use on patients until you confirm you have a different lot or model
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-1407-2026More 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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