Data Foundry

Medical device recalls 2026

Brand Name: da Vinci S — Class II medical device recall Z-1701-2026

Ongoing recall by Intuitive Surgical, Inc., reported 2026-04-08, distributed nationwide. Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Recall numberZ-1701-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIntuitive Surgical, Inc., Sunnyvale, CA, United States
Recall initiated2025-12-09
Classified2026-03-30
Reported by FDA2026-04-08
DistributedNationwide (US)
Countries outside the USAE, AR, AT, BE, BR, CA, CH, CL, CN, CO, CY, CZ, DE, EC, EG, ES, FR, GB, GR, HK, ID, IN, IT, JP, KR, KW, LB, MX, MY, PH, PK, PT, QA, RO, SA, TH, TR, TW, UY, VE, VN, ZA
Quantity6,152 instruments
UPC / GTIN / UDI-DI00886874111536
Lot numbers420183
Model numbers420183

Product

Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 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 in complaints regarding frayed or broken pitch cables on reusable surgical 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-1701-2026. 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.