The Recall Desk
HighFDA (Devices)·Z-2487-2026·Announced 2026-06-24

[pending] MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERG

Pending LLM rewrite. Source: FDA_DEVICE Z-2487-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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)
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each)
  • 40193489344241 (case)
  • Lot Number 21ABD933
  • Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each)
  • 40193489847124 (case)
  • Lot Number 22IBJ338
  • Lot Number 22EBL456
  • Lot Number 22EBL231
  • Lot Number 22BBW955
  • Lot Number 22ABC123
  • Lot Number 21IBM442
  • Lot Number 21IBI539
  • Lot Number 21FBT730
  • Lot Number 21EBA066
  • Lot Number 21CBW872
  • Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each)
  • 40195327233618 (case)
  • Lot Number 23HBV936
  • Lot Number 23HBL135
  • Lot Number 23HBH924

Distribution

Distributed nationwide across the United States.

Related recalls

Same category