- 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)
- ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); UDI-DI: 25051684005712(Box), 15051684005715(Pouch); Lot No.: A2725033, A2725034, A3525048, A3525049;
- Units affected
- 515 units (103 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-1872-2026
- 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