The Recall Desk
HighFDA (Devices)·Z-1456-2025·Announced 2025-04-16

[pending] Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CAB

Pending LLM rewrite. Source: FDA_DEVICE Z-1456-2025.

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

Medline medical procedure kits, containing Medtronic Aortic Root Cannula

The recalled product

Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
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)

  • CABG OPNHRT S HSP
  • UDI/DI 10195327449650 (EA) 40195327449651 (case)
  • Lot Numbers 23IBH906
  • 24EBC446
  • 24FMC989
  • 24GME639
  • UDI/DI 10198459089503 (EA) 40198459089504 (case)
  • Lot Numbers 24KMB217
  • 25AMG162
  • CARDIAC CABG
  • UDI/DI 10195327490362 (EA) 40195327490363 (case)
  • Lot Numbers 23LBV500
  • 24DBS178
  • 24EBK724
  • 24FBL825
  • CARDIAC PACK
  • UDI/DI 10195327490355 (EA) 40195327490356 (case)
  • Lot Numbers 24CBN830
  • 24DBS177
  • DR D AC PACK

Distribution

Distributed in 9 states:

  • CA
  • FL
  • MN
  • NY
  • OH
  • OR
  • PA
  • TX
  • WV

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