The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1456-2025·Announced 2025-04-16

Medline medical procedure kits with Medtronic Aortic Root Cannula recalled

Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA's own classification is Class I, which per the rubric criterion mandates a minimum score of 4. This is a Class I medical device recall involving surgical equipment used in cardiac procedures.

Plain-English summary

Medline Industries, LP is recalling Medline medical procedure kits that contain a Medtronic Aortic Root Cannula. The recalled kits are labeled as 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, and Z OPEN HEART. A total of 1,310 units have been recalled.

The kits were distributed to healthcare facilities in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. The FDA has classified this as a Class I recall.

Healthcare facilities that received these kits should review the lot numbers and UDIs provided by the FDA and contact Medline Industries or the FDA if they have questions about whether their inventory is affected. Facilities should follow their standard protocols for handling recalled medical devices.

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…
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Cardiac Procedure Kits
Hazard
Affected units
1,310

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:

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 →

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