Heparin — Class II medical device recall Z-0077-2022
Ongoing recall by W L Gore & Associates, Inc., reported 2021-10-20. Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may conta
| Recall number | Z-0077-2022 |
|---|---|
| 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 | 2021-09-07 |
| Classified | 2021-10-08 |
| Reported by FDA | 2021-10-20 |
| Countries outside the US | IT, LB |
| Quantity | 2 units |
| Reason classes | labeling |
| Serial numbers | 22753580 |
| Model numbers | BXAL085902E |
Product
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
Reason for recall
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
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-0077-2022. 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.