MYNXGRIP 5F — Class II medical device recall Z-0674-2024
Ongoing recall by Cordis US Corp, reported 2024-01-17, distributed in CA, MI, MS, NC, OH, TN, WV. Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two l
| Recall number | Z-0674-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis US Corp, Miami Lakes, FL, United States |
| Recall initiated | 2023-11-28 |
| Classified | 2024-01-05 |
| Reported by FDA | 2024-01-17 |
| Distributed | CA, MI, MS, NC, OH, TN, WV |
| Quantity | 50 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10862028000403 |
| Lot numbers | F2322902 |
| Model numbers | MX5021 |
Product
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Reason for recall
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
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-0674-2024. 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.