Quick Facts at a Glance
- Recall Date
- December 9, 2025
- Hazard Level
- HIGH
- Brand
- Intuitive Surgical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Intuitive Surgical
- Product type
- EndoWrist Tenaculum Forceps Instrument
- Model numbers
- 420207, Lot Code: 420207, 420207-06, 420207-07, 420207-09, 420207-10, da Vinci System Numbers: SH1378 SH0935 SH1368 SH1390 SH0729 SH1385 SH1279 USG294 USG022
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 9, 2025
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
EndoWrist instruments are reusable robotic surgical tools used with the da Vinci system to manipulate tissue during procedures. The Tenaculum Forceps Instrument is used for grasping and tissue manipulation.
Why This Is Dangerous
Frayed or broken pitch cables can compromise the instrument’s motion transmission, reducing control during surgery and potentially causing tissue injury.
Industry Context
This recall is not presented as part of a broader standard pattern in this release.
Real-World Impact
Hospitals and surgeons may face equipment downtime, delayed surgeries, and potential safety risks if affected instruments are used.
Practical Guidance
How to identify if yours is affected
- Check instrument model 420207 and lot codes starting with 420207.
- Review da Vinci EndoWrist instruments in use for the same lot code.
- Consult your facility’s inventory to identify affected units.
Where to find product info
Recall notice and instrument labels show model 420207 and lot code 420207; refer to Intuitive Surgical communications and FDA recall Z-1700-2026.
What timeline to expect
Replacement or refund timelines will be provided by Intuitive Surgical in their recall communications; typical timelines range weeks to months.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Escalate to hospital risk management or legal counsel if needed.
How to prevent similar issues
- Request updated instrument guidance from Intuitive Surgical before next procurement.
- Verify instrument lot codes during receiving inspections.
- Maintain a clear recall contact channel within the hospital procurement team.
Documentation advice
Keep the recall letter, serial and lot codes, date of purchase, and all correspondence with the manufacturer.
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Product Details
Brand: Intuitive Surgical Product: da Vinci S, Si EndoWrist Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Quantity recalled: 2,095 instruments Distribution: U.S. nationwide in AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, WA; Numerous listed countries Classification: Class II Hazard: Frayed or broken pitch cables that transmit motion from input discs to the distal tip Remedy: Stop using the device immediately. Follow recall instructions. Contact Intuitive Surgical or healthcare provider for instructions Recall site
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall number Z-1700-2026
- Instruments are reusable EndoWrist tools compatible with the da Vinci system
- Hazard: frayed or broken pitch cables
- No injuries or incidents reported at this time
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Safety Guide
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