Visualase Cooled Laser Applicator System — Class II medical device recall Z-0244-2023
Ongoing recall by Medtronic Navigation, Inc., reported 2022-11-23, distributed nationwide. Due to a defect in the outer pouch sterile seal
| Recall number | Z-0244-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2022-10-14 |
| Classified | 2022-11-17 |
| Reported by FDA | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 95 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00763000416430 |
| Lot numbers | 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769 |
Product
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
Reason for recall
Due to a defect in the outer pouch sterile seal
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-0244-2023. 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.