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 Grasping Retractor Instrument
- Model numbers
- 420278, 420278-04, 420278-06, 420278-07, 420278-09
- 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 surgical tools used for endoscopic manipulation, including grasping, dissection, suturing, and delivery of ablation probes. They rely on tungsten cables and pulleys to transmit motion from the input discs to the distal tip.
Why This Is Dangerous
Wear or breakage of grip cables can compromise instrument control and ergonomics during procedures, potentially impacting patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals may need to quarantine affected instruments, adjust inventory, and coordinate with Intuitive for replacements. The recall could affect surgical schedules and equipment availability.
Practical Guidance
How to identify if yours is affected
- Verify model number 420278 on the instrument label.
- Review batch/lot numbers listed in the recall details.
- Consult Intuitive Surgical for recall-specific disposition instructions.
Where to find product info
Recall notices are available through the FDA enforcement page and the manufacturer’s recall communications.
What timeline to expect
Typically 4-8 weeks for replacement or remediation once processed by the manufacturer and hospital procurement channels.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to hospital risk management and medical device regulatory channels.
- File a formal inquiry with the FDA if necessary.
How to prevent similar issues
- Before purchasing, verify the instrument model against the recall list.
- Maintain an up-to-date inventory of EndoWrist instruments and batch codes.
- Ask suppliers for recall status and replacement timelines before accepting shipments.
Documentation advice
Keep the recall notice, serial and batch numbers, purchase records, and correspondence with the manufacturer. Photograph labels and packaging for audit trails.
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Product Details
Model/Catalog Number: 420278; Brand: Intuitive Surgical; Product: da Vinci S, Si Grasping Retractor Instrument; Recall Date: 2025-12-09; Status: ACTIVE; Quantity: 2660; Distribution: Worldwide. U.S. statewide distribution includes CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI. Additional countries include Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model/Catalog Number: 420278.
- Worldwide distribution with specific U.S. state coverage listed.
- Hazard: broken/frayed grip cables on reusable EndoWrist instruments.
- No injuries or incidents reported to date.
- Follow manufacturer recall instructions and contact Intuitive Surgical for guidance.
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Safety Guide
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