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 reusable instrument (EndoWrist) with Permanent Cautery Hook
- Model numbers
- 420183, 420183-05, 420183-06, 420183-10, 420183-11, 420183-12, 420183-14, 420183-15 +3 more
- 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
These are EndoWrist reusable endoscopic instruments used with the da Vinci S/Si systems for tissue manipulation during minimally invasive procedures. They transmit motion through pitch cables to control the distal tip.
Why This Is Dangerous
Frayed or broken pitch cables can compromise instrument control and performance during surgery, creating a risk of unintended instrument movement.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Facilities may need to pause certain procedures and inventory affected devices for replacement or return, potentially affecting surgical schedules and supply chains.
Practical Guidance
How to identify if yours is affected
- Verify model number 420183 on the instrument label.
- Inspect the pitch cable area for fraying or damage.
- Check lot codes if available (e.g., 420183-related codes).
Where to find product info
Model 420183 and related material numbers, GTIN 00886874111536, FDA Listing D088920 on the device and packaging.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after verification of eligibility.
If the manufacturer is unresponsive
- Escalate to hospital risk management or regulatory authorities.
- Document all communications and keep copies of recall notices.
How to prevent similar issues
- Inspect EndoWrist instruments before use.
- Avoid reusing damaged instruments and replace per manufacturer guidance.
Documentation advice
Keep serial numbers, lot codes, purchase records, and correspondence with the manufacturer for the recall process.
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Product Details
Model/Catalog Number: 420183 Lot Code: 420183 GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05, 420183-06, 420183-10, 420183-11, 420183-12, 420183-14, 420183-15, 420183-16 System Numbers: USG294; SH0059; SH0075; SH1378; SH1182; SH1390; SH2144; SG704; USG721 Distribution: United States 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; Countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadelu
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- National U.S. distribution across 23+ states listed; 27+ countries listed
- Model 420183 with multiple material and system numbers
- Recall date 2025-12-09; status ACTIVE; hazard HIGH
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Safety Guide
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