IS4000 da Vinci Xi — Class II medical device recall Z-1871-2014
Terminated recall by Intuitive Surgical, Inc., reported 2014-07-02, distributed in FL, NY, TX. In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical
| Recall number | Z-1871-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-06-11 |
| Classified | 2014-06-25 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-07-02 |
| Distributed | FL, NY, TX |
| Quantity | 19 units |
Product
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.
Reason for recall
In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue
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-1871-2014. 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.