The Recall Desk
HighFDA (Devices)·Z-1459-2025·Announced 2025-04-16

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

Pending LLM rewrite. Source: FDA_DEVICE Z-1459-2025.

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: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M 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 (20)

  • TOL DR R PACK
  • UDI/DI 10198459054242 (ea) 40198459054243 (case)
  • Lot Number 24IBV027
  • TOL DR. C PACK
  • UDI/DI 10195327176914 (ea) 40195327176915 (case)
  • Lot Number 22HBX339
  • TOL DR. CRESCENZO PACK
  • UDI/DI 10195327273750 (ea) 40195327273751 (case)
  • Lot Numbers 22LBC389
  • 23EBQ439
  • 23HBG138
  • UDI/DI 10195327513818 (ea) 40195327513819 (case)
  • Lot Numbers 23KBS878
  • 24CBB191
  • 24EBD828
  • UDI/DI 10198459054259 (ea) 40198459054250 (case)
  • Lot Numbers 24FBO426
  • 24HBP282
  • 24JBL545
  • 24LBR173

Distribution

Distributed in 9 states:

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

Related recalls

Same category