Product Wiki · Recalls · U.S. FDA — Device Enforcement

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches; — recall Z-1860-2026

U.S. FDA — Device Enforcement · United States · 2026-03-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1860-2026
Date of alert
2026-03-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10714009
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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