FDA recall, , Moderate risk
Intuitive Surgical da Vinci S, Si Tenaculum Forceps and Permanent Cautery Hook Instruments
The da Vinci S, Si Tenaculum Forceps Instrument has frayed or broken pitch cables.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, is recalling the da Vinci S, Si Permanent Cautery Hook Instrument and the da Vinci S, Si Tenaculum Forceps Instrument due to increased complaints regarding frayed or broken pitch cables on reusable surgical instruments.
The instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps, needle holders, retractors, electrocautery and accessories. The recall began on December 9, 2025, and was added to the FDA's Enforcement Report on March 30, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
da Vinci S, Si Permanent Cautery Hook Instrument
- UDI-DI
- 00886874111536
- Model/Catalog number
- 420183
da Vinci S, Si Tenaculum Forceps Instrument
- UDI-DI
- 00886874111659
- Model/Catalog number
- 420207
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arkansas, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Texas, Virginia, and Washington. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98408
- Recall numbers
- Z-1700-2026 to Z-1701-2026
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
