Medline medical procedure kits — Class I medical device recall Z-1459-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-16, distributed in CA, FL, MN, NY, OH, OR, PA, TX…. Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential exce
| Recall number | Z-1459-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-02-21 |
| Classified | 2025-04-04 |
| Reported by FDA | 2025-04-16 |
| Distributed | CA, FL, MN, NY, OH, OR, PA, TX, WV |
| Quantity | 1,247 units |
| UPC / GTIN / UDI-DI | 10195327176914, 10195327273750, 10195327513818, 10195327513825, 10198459054242, 10198459054259, 10198459054266, 40195327176915, 40195327273751, 40195327513819, 40195327513826, 40198459054243, 40198459054250, 40198459054267 |
| Lot numbers | 22HBX339, 22LBC389, 23EBQ439, 23HBG138, 23KBC932, 23KBS878, 24CBB191, 24CBP602, 24EBD828, 24EBV519, 24FBO426, 24GBI558, 24GBX898, 24HBP282, 24IBE173, 24IBE173A, 24IBV027, 24JBL545, 24LBR173, 25ABG352 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1459-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.