Brand Name: da Vinci S — Class II medical device recall Z-1697-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-04-08, distributed nationwide. Due to increased complaints for broken/frayed grip cables for reusable instruments.
| Recall number | Z-1697-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2025-12-09 |
| Classified | 2026-03-30 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BR, CA, CH, CL, CN, CY, CZ, DE, EC, FR, GB, GR, ID, IN, IT, JP, KR, KW, LB, MX, MY, PH, PK, PT, QA, RO, SA, TH, TR, TW, UY, VE, VN |
| Quantity | 2,370 |
| UPC / GTIN / UDI-DI | 00886874111581 |
| Lot numbers | 420189 |
| Model numbers | 420189 |
Product
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Reason for recall
Due to increased complaints for broken/frayed grip cables for reusable instruments.
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-1697-2026. 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.