NvisionVLE¿ Low-Profile Optical Probe — Class II medical device recall Z-1781-2018
Terminated recall by Ninepoint Medical Inc., reported 2018-05-16, distributed nationwide. Distal tips of the probes may detach from the probe shaft during use.
| Recall number | Z-1781-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ninepoint Medical Inc., Bedford, MA, United States |
| Recall initiated | 2018-04-11 |
| Classified | 2018-05-09 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2018-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 152 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00859591006188 |
| Lot numbers | 005196, 005251, 005275 |
| Model numbers | 95501-LP, 95501-LP-5 |
Product
NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.
Reason for recall
Distal tips of the probes may detach from the probe shaft during use.
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-1781-2018. 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.