Da Vinci Single-Site Wristed Needle Driver — Class II medical device recall Z-0406-2024
Ongoing recall by Intuitive Surgical, Inc., reported 2023-12-06, distributed in CA, CO, FL, ID, IL, MI, MS, NJ…. There is the potential for the needle drive to become dislodged and/or broken which could result in uncontroll
| Recall number | Z-0406-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2023-10-06 |
| Classified | 2023-11-28 |
| Reported by FDA | 2023-12-06 |
| Distributed | CA, CO, FL, ID, IL, MI, MS, NJ, NY, OR, PR, SC, TN, TX |
| Countries outside the US | KR |
| Quantity | 317 units |
| UPC / GTIN / UDI-DI | 00886874113752 |
| Serial numbers | T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109 |
| Model numbers | 478115 |
Product
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Reason for recall
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
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-0406-2024. 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.