AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the… — Class II medical device recall Z-1406-2013
Terminated recall by Angiodynamics, Inc., reported 2013-06-05, distributed nationwide. AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because th
| Recall number | Z-1406-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2013-04-30 |
| Classified | 2013-05-25 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2016-11-09 |
| Distributed | Nationwide (US) |
| Model numbers | 11403301, 11403302, 11403304 |
Product
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Reason for recall
AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.
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-1406-2013. 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.