Soft-Vu Angiographic Catheter — Class II medical device recall Z-1862-2026
Ongoing recall by Angiodynamics, Inc., reported 2026-04-29, distributed nationwide. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from p
| Recall number | Z-1862-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2026-03-03 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CL, CN, CW, CZ, DE, ES, IE, IL, IT, LB, NL, NZ, PA, SE, SI, TH, ZA |
| UPC / GTIN / UDI-DI | 15051684007894, 25051684007891 |
| Lot numbers | A2825033, A2825034, A2825132, A2825133, A3725048, A3725049 |
| Model numbers | 10714014 |
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Reason for recall
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
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-1862-2026. 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.