Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrum

FDA device recall Z-1701-2026 · posted 2026-03-30 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Action taken

On 12/29/2025, the firm email and sent via overnight priority mail an "Urgent: Medical Device Recall" letter to customers informing them of possible pitch cable failures on the da Vinci S and Si Tenaculum Forceps and Permanent Cautery Hooks reusable instruments. Customers are instructed to: 1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 2. Please identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service. 3. Please ensure to include the FSCA number ISIFA2025-16-R in your return notes. 4. Credit will be provided based on the number of remaining lives. 5. If affected products were shared or further distributed with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product. 6. Please retain a copy of this letter and the acknowledgement form for your files. 7. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For further information or support, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)

Root cause

Process change control

Status

Open, Classified

Product code

NAY

Quantity affected

6152 instruments

Distribution

U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil,

Date initiated

2025-12-09

Date posted

2026-03-30

Location

Sunnyvale, CA

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