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
- Endoscopic Grasper Instrument
- Model numbers
- 420189
- 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 complaints for broken/frayed grip cables for reusable 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
The da Vinci S/Si EndoWrist instruments are reusable robotic surgery tools used to manipulate tissue during procedures. They rely on mechanical cables to transmit motion from input discs to the distal tip.
Why This Is Dangerous
A broken or frayed grip cable can compromise instrument control during surgery, potentially affecting performance and precision.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to quarantine affected instruments and arrange replacements, potentially delaying procedures and increasing administrative burden.
Practical Guidance
How to identify if yours is affected
- 1. Locate model 420189 on the instrument or packaging.
- 2. Check for Lot Code 420189 and GTIN 00886874111581.
- 3. Review any associated materials for additional codes (e.g., Material Number 420189-07).
- 4. Compare with recall list to confirm status.
Where to find product info
Official recall notices on FDA enforce pages and Intuitive Surgical patient safety communications.
What timeline to expect
Replacement or repair arrangements will be communicated by the manufacturer; typical timelines vary by hospital supply chain.
If the manufacturer is unresponsive
- Document all inquiries and escalate to hospital risk management; consider filing a formal inquiry with the manufacturer and FDA as needed.
- Maintain quarantine of affected devices until replacement is arranged.
How to prevent similar issues
- Regularly review recall databases for surgical instruments.
- Verify instrument model and batch codes before use.
- Establish supplier alerts for EndoWrist instruments.
- Confirm instrument integrity before any procedure.
Documentation advice
Keep recall notification, hospital correspondence, device batch codes, and replacement records for audits and claims.
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Product Details
Brand: Intuitive Surgical. Product: da Vinci S/Si Double Fenestrated Grasper Instrument. Model/Catalog Number: 420189. Software Version: NA. Quantity recalled: 2370. Distribution: Worldwide, including CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI; Countries listed in recall. Recall date: 2025-12-09. Status: ACTIVE. Hazard: Broken or frayed grip cables. Manufacturer: Intuitive Surgical, Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including listed US states
- Hazard: broken/frayed grip cables
- No injuries reported
- Recall date 2025-12-09; Status ACTIVE
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Safety Guide
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