FDA Device recall Z-1459-2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B…
- 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: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B… by Medline Industries Northfield, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1459-2025 |
| 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: 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.
Reason
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.
Identifiers
| code_info | TOL DR R PACK, UDI/DI 10198459054242 (ea) 40198459054243 (case), Lot Number 24IBV027; TOL DR. C PACK, UDI/DI 101953271…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; TOL DR. C PACK, UDI/DI 10195327513818 (ea) 40195327513819 (case), Lot Numbers 23KBS878, 24CBB191, 24EBD828; TOL DR. C PACK, UDI/DI 10198459054259 (ea) 40198459054250 (case), Lot Numbers 24FBO426, 24HBP282, 24JBL545, 24LBR173; TOL DR. M PACK, UDI/DI 10195327513825 (ea) 40195327513826 (case), Lot Numbers 23KBC932, 24CBP602, 24EBV519; TOL DR. M PACK, UDI/DI 10198459054266 (ea) 40198459054267 (case), Lot Numbers 24GBI558, 24GBX898, 24IBE173, 24IBE173A, 25ABG352. |
|---|
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-1459-2025%22
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