MEDLINE OPEN HEART PACK — Class II medical device recall Z-0121-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-23, distributed nationwide. Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel C
| Recall number | Z-0121-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-08-28 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 123 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10193489853360, 40193489853361 |
| Lot numbers | 23LBH354, 23LBM368 |
| Model numbers | DYNJ66216C |
Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Reason for recall
Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
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-0121-2025. 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.