VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref — Class II medical device recall Z-1819-2022
Ongoing recall by Angiodynamics, Inc., reported 2022-10-05, distributed nationwide. OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specifi
| Recall number | Z-1819-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2022-08-10 |
| Classified | 2022-09-27 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 40 units |
| UPC / GTIN / UDI-DI | 25051684014653 |
| Lot numbers | 5728621 |
| Model numbers | EVLT55OPS |
Product
VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
Reason for recall
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged sheath will necessitate removal from the patient, which may result in procedural delay and/or surgical intervention
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-1819-2022. 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.