Medline triple lumen insertion kit recalled for potential sterilization failure
Stop using Medline triple lumen insertion kit
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
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 Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief