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
- Needle Driver Instrument
- Model numbers
- 420194
- 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 Mega Needle Driver Instrument is part of the EndoWrist family used with robotic surgical systems. It enables tissue manipulation, suturing, and probe delivery during minimally invasive procedures.
Why This Is Dangerous
The defect involves broken or frayed grip cables that transmit motion from the input discs to the distal tip, potentially compromising control during surgery.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
Hospitals and surgical teams must discontinue use of affected devices and arrange replacements or repairs to avoid intraoperative complications and potential delays.
Practical Guidance
How to identify if yours is affected
- Locate your instrument model on the device or packaging: 420194.
- Review batch/system numbers listed in recall materials.
- Check GTIN 00886874111611 and FDA Listing D088920.
- Consult hospital records to identify affected lots.
Where to find product info
Serials, batch codes, and model numbers are on the instrument label, packaging, or accompanying documentation. The FDA recall page provides the official listing.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after approval of the recall remedy.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement if the supplier is slow to respond.
- File a recall report with the FDA if applicable.
- Consult the hospital’s legal/compliance team for guidance on remediation.
How to prevent similar issues
- Verify instrument model and batch numbers before use in procedures.
- Register instrument recalls with hospital risk management and procurement.
- Request replacement instruments when recalls are announced.
- Keep all recall communications and documentation for audits.
Documentation advice
Keep a copy of the recall notice, records of all communications with the manufacturer, and any replacement instrument details.
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Product Details
Model/Catalog Number: 420194. Quantity recalled: 7,819 units. Distribution: Worldwide, including US states CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI; countries listed in recall notice. GTIN: 00886874111611. FDA Medical Device Listing Number: D088920.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 7,819 units recalled worldwide
- FDA Listing D088920
- Worldwide distribution including 20+ US states and dozens of countries
- Hazard: broken/frayed grip cables can impair instrument control
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Safety Guide
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