Angiodynamics recalls VenaCure EVLT Procedure Kits with Spotlight Ops Sheath 55cm (EVLT55OPS) due to potential sheath damage causing procedural delays or surgery. Affected kits have specific UDI-DI and lot numbers.
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
Take action
Contact the company
📍Recalling firmAngiodynamics, Inc.603 Queensbury Ave · Queensbury, NY 12804-7619
“Angiodynamics VenaCure EVLT Kit with Spotlight Ops Sheath 55cm Recall: Sheath Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60199-angiodynamics-venacure-evlt-kit-with-spotlight-ops-sheath-55cm-recall. Based on FDA recall #Z-1819-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1819-2022%22&limit=1).
The FDA announced on August 10, 2022, that Angiodynamics, Inc. is recalling VenaCure EVLT Procedure Kits due to a dimensional defect in the OPS Fiber that may damage the sheath. The agency classified the recall as Class II.
How to tell if you have it
Brand: Angiodynamics
Product: VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM
Catalog No.: EVLT55OPS
Lot Number: 5728621
UPN: H787EVLT55OPS5
Units affected: 40
Distribution: US Nationwide in FL, NC, NJ, NM, NY, PA, TX, VA
The hazard
The OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification. This defect 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.
Context
GovInfoNow's records show Angiodynamics, Inc. has had 18 other recalls on record since June 5, 2017. Other recent recalls of similar products include the Angiodynamics Soft-Vu Catheter Recall (March 3, 2026), the Angiodynamics IsoLoc Prostate Balloon Kit Recall (February 4, 2025), and the Angiodynamics Auryon Laser System Recall (November 25, 2024). Other recent recalls of similar products include the Oscor Abiomed Introducer Kit Recall (June 10, 2026), the Abiomed Intro Kit Recall (June 11, 2026), and the Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026).
How to tell if you have this one
Check for the product name 'VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM' and catalog number EVLT55OPS. Each box contains 5 Procedure Kits. The UDI-DI is 25051684014653 and lot number 5728621.
Brand
Angiodynamics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product by catalog number EVLT55OPS or UDI-DI 25051684014653.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, New Jersey, New Mexico, New York, North Carolina, Pennsylvania, Texas, Virginia.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1819-2022 (August 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1819-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.