Da Vinci 5 ASSY — Class II medical device recall Z-1428-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-02-25, distributed in LA, MA, NY, PA, TX, VA. An error event following the release of a software version for the surgical system that can result in loss of
| Recall number | Z-1428-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2025-11-17 |
| Classified | 2026-02-18 |
| Reported by FDA | 2026-02-25 |
| Distributed | LA, MA, NY, PA, TX, VA |
| Quantity | 12 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00886874119747 |
| Model numbers | 380730 |
Product
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.
Reason for recall
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
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-1428-2026. 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.