The Recall Desk
HighFDA (Devices)·Z-1457-2025·Announced 2025-04-16

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1457-2025.

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

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.

The recalled product

Product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
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 (12)

  • TOL DR R PACK
  • UDI/DI 10195327166304 (ea) 40195327166305 (case)
  • Lot Numbers 22GBL197
  • 22JBG283
  • UDI/DI 10195327273484 (ea) 40195327273485 (case)
  • Lot Numbers 23ABO787
  • 23EBT153
  • 23HBB950
  • UDI/DI 10195327503390 (ea) 40195327503391 (case)
  • Lot Numbers 24CBL126
  • 24EBV315
  • 24EBW136.

Distribution

Distributed in 9 states:

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

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