- Recalling firm
- Angiodynamics, Inc.
- 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.
- Affected products (lot / model / serial)
- SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); UDI-DI: 25051684007914(Box), 15051684007917(Pouch); Lot No.: A2525098;
- Units affected
- 1030 units (206 boxes)
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand.
- Firm location
- Queensbury, NY, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1863-2026
- Recall initiated
- March 3, 2026
- FDA classification date
- April 17, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98463
- Last updated on HTM Vibe
- July 24, 2026