Device recall

Z-1456-2025: Medline medical procedure kits, containing Medtronic Aortic Root Cannula…

FDA device recall · Class I · MEDLINE INDUSTRIES, LP - Northfield

Key facts

Recall number (Z-number) Z-1456-2025
Recall event 96443
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.
Product code OEZ
Recalling firm MEDLINE INDUSTRIES, LP - Northfield
Recall class Class I
Status Open, Classified
FEI number 1417592

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)