Heparin — Class II medical device recall Z-2946-2024
Ongoing recall by W L Gore & Associates, Inc., reported 2024-09-11, distributed nationwide. Due to packaging defects, sterility assurance and heparin activity may be compromised.
| Recall number | Z-2946-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2024-07-01 |
| Classified | 2024-08-30 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 100 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00733132657926, 00733132657940, 00733132657957, 00733132657964, 00733132657971, 00733132657988, 00733132657995, 00733132658008, 00733132658015, 00733132658022, 00733132658039, 00733132658046, 00733132658053 |
Product
Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.
Reason for recall
Due to packaging defects, sterility assurance and heparin activity may be compromised.
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-2946-2024. 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.