Medline open-heart and cardiac surgery kits recalled for catheter defects
What this means
Medline identified that certain batches of medical procedure kits used in open-heart and cardiac surgeries did not meet quality standards. Issues found include surface irregularities on catheters, connectors that may detach prematurely, and catheters with incorrect outer diameters. No injuries have been reported.
- Check if your facility has any of the affected kit lot numbers listed in the recall notice.
- Do not use affected kits for procedures.
- Contact Medline or your supplier for instructions on returning or replacing the kits.
- Review your surgical inventory immediately if you perform open-heart or cardiac procedures.
The agency's original wording
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2487-2026More 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.