FDA Device recall Z-1456-2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK…
- FDA Device
- Class I
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class I recall of Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK… by Medline Industries Northfield, citing medline medical procedure kits, containing Medtronic Aortic Root Cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1456-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-21 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | CA, FL, MN, NY, OH, OR, PA, TX, WV |
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.
Reason
Medline medical procedure kits, containing Medtronic Aortic Root Cannula
Identifiers
| code_info | CABG OPNHRT S HSP, UDI/DI 10195327449650 (EA) 40195327449651 (case), Lot Numbers 23IBH906, 24EBC446, 24FMC989, 24GME63…CABG OPNHRT S HSP, UDI/DI 10195327449650 (EA) 40195327449651 (case), Lot Numbers 23IBH906, 24EBC446, 24FMC989, 24GME639; CABG OPNHRT S HSP, 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, UDI/DI 10195327298258 (EA) 40195327298259 (case), Lot Numbers 23HBD834, 23IBF066; HEART BASIN PACK-LF, UDI/DI 10195327047573 (EA) 40195327047574 (case), Lot Numbers 22GMD767, 22JMD290, 23GMC713, 23IMA561, 23KMC902; K OH COMPONENT PACK, UDI/DI 10195327659684 (EA) 40195327659685 (case), Lot Numbers 24EBT996, 24IBR766, 24KBJ595, 24LBQ493; OPEN HEART ADULT PART 1 CDS, UDI/DI 10195327034726 (EA) 40195327034727 (case), Lot Number 24CBG813; OPEN HEART B PACK-LF, UDI/DI 10195327206383 (EA) 40195327206384 (case), Lot Numbers 22IMH938, 22KMC295 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1456-2025%22
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