VS3 Iridium Visionsense Infrared — Class II medical device recall Z-0282-2023
Ongoing recall by Visionsense, Ltd., reported 2022-11-30, distributed nationwide. Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality
| Recall number | Z-0282-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Visionsense, Ltd., Petakh Tikva, N/A, Israel |
| Recall initiated | 2022-10-17 |
| Classified | 2022-11-23 |
| Reported by FDA | 2022-11-30 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 18130400103625 |
| Lot numbers | 361-0012, 361-0901, 361-0902, 361-0903, 361-0904, 361-0906, 361-0907, 361-0908, 361-0909, 361-0910, 361-0911, 361-0913, 361-0914, 361-0915, 361-0916, 361-0917, 361-0918, 361-0919, 361-0921, 361-0922, 361-0923, 361-0924, 361-0926, 361-0929, 361-0931, 361-0932, 361-0933, 361-0937, 361-0938, 361-0940, 361-0941, 361-0943, 361-0944, 361-0945, 361-0955, 361-0966, 361-0970, 361-1013, 361-1061, 361-1067 and 164 more |
Product
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
Reason for recall
Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
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-0282-2023. 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.