FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline open-heart and cardiac surgery kits recalled for catheter defects

OTHERNationwide distribution

Medline cardiac procedure kits recalled for catheter defects

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.
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
168968 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2487-2026

More Medline Industries, LP recalls

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