Brand Name: Da Vinci 5 Product Name: ASSY — Class II medical device recall Z-2310-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-06-10, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during
| Recall number | Z-2310-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2026-04-24 |
| Classified | 2026-06-04 |
| Reported by FDA | 2026-06-10 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AU, BE, CH, DE, ES, FR, GB, IT, JP, KR, NL, NZ, PL, RO, SA |
| Quantity | 1,357 systems |
| UPC / GTIN / UDI-DI | 00886874119662 |
| Serial numbers | 1008007, 1008008, 1008009, 1008010, 1008011, 1008012, 1008013, 1008015, 1008016, 1008017, 1008020, 1008021, 1008022, 1008024, 1008100, 1008101, 1008102, 1008104, 1008105, 1008107, 1008108, 1008109, 1008112, 1008113, 1008114 and 475 more |
| Model numbers | 380746, 470653-01, 470653-03, DV5 |
Product
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
Reason for recall
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
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-2310-2026. 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.