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

Medline Medical Procedure Kits with Medtronic Aortic Cannula Recalled

Medline medical procedure kits containing a Medtronic Aortic Root Cannula are being recalled due to potential excess material in the male lures on the aortic cannula. The kits were distributed in nine US states.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall of a medical device used in cardiac surgery, which by rule cannot score below 4. The potential for excess material in a critical component of an aortic cannula poses a risk of harm during high-risk surgical procedures.

Plain-English summary

Medline Industries, LP is recalling medical procedure kits that contain a Medtronic Aortic Root Cannula. The recalled kits are labeled as CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, and TOL DR. M PACK. A total of 1,247 units were distributed in the United States.

The recall is due to the potential presence of excess material in the male lures on the aortic cannula. The affected products were distributed to facilities in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia.

The FDA has classified this as a Class I recall. Consumers and healthcare facilities that have received these kits should stop use immediately and contact Medline Industries, LP for instructions on return or replacement of the affected products.

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 — Cardiac Surgery / Perfusion
Hazard
Affected units
1,247

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:

Part of a larger recall action

This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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Same hazard · defective component

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