Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath — Class II medical device recall Z-1320-2023
Ongoing recall by Biosense Webster, Inc., reported 2023-04-12, distributed nationwide. Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Dir
| Recall number | Z-1320-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irvine, CA, United States |
| Recall initiated | 2023-02-21 |
| Classified | 2023-03-31 |
| Reported by FDA | 2023-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 316 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10846835016277 |
| Lot numbers | 50000224 |
| Model numbers | 2797, D-1385-02-S |
Product
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Reason for recall
Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
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-1320-2023. 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.