PINPOINT Endoscopic Fluorescence Imaging System — Class II medical device recall Z-1032-2016
Terminated recall by Novadaq Technologies Inc., reported 2016-03-09, distributed nationwide. It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-c
| Recall number | Z-1032-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novadaq Technologies Inc., Burnaby, N/A, Canada |
| Recall initiated | 2016-01-29 |
| Classified | 2016-03-02 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | BD, CA, HK, IL, IN |
| Quantity | 110 units |
| Model numbers | PC9000 |
Product
PINPOINT Endoscopic Fluorescence Imaging System
Reason for recall
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
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-1032-2016. 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.