VS3 Iridium — Class II medical device recall Z-0281-2023
Ongoing recall by Visionsense, Ltd., reported 2022-11-30, distributed nationwide. XXX
| Recall number | Z-0281-2023 |
|---|---|
| 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 | 10813040013711 |
| Lot numbers | 378-4005, 378-4514, 378-4516, 378-4517, 378-4518, 378-4519, 378-4520, 378-4521, 378-4522, 378-4523, 378-4525, 378-4526, 378-4527, 378-4528, 378-4534, 378-4586, 3784692, 3784693, 3784694, 3784696, 3784700, 3784701, 3784702, 3784703, 3784704, 3784784, 3784786, 3784787, 3784802, 3784803, 3784807, 3784808, 3784874, 3784875 |
Product
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Reason for recall
XXX
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-0281-2023. 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.