EndoWrist recallZ-2059-2023 · Intuitive Surgical, Inc. · initiated Jun 12, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
FDA root cause category: Process control
What the company is doing
On 6/12/23 Field Safety Notices were mailed and emailed to customers asking them to do the following: 1) Locate and return affected devices. 2) Notify all surgeons and users of the device about the contents of the notice. 3) Complete and return the acknowledgement form to [email protected] If you need further information or support concerning this Medical Device Notification, please contact your Clinical Sales Representative or contact Customer Service at: - North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] - South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) - Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) - India: +1-800-103-6952 (9 AM to 6 PM IT) - Taiwan: +0800-86-8181 (9 AM to 6 PM CT)
Recall details
- Recall number
- Z-2059-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 12, 2023
- Posted by the FDA
- Jun 30, 2023
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 46,033
- Product code
- NAY
- FDA submissions
- K131861
- Distribution
- Worldwide - US Nationwide distribution in the states of PR, FL, MN, PA, AZ, OH, IL, NC, GA, KS, CA, HI, MD, OR, SC, AK, NY, NE, IA, WA, OK, ND, UT, MS, AR, WI, MI, TX, TN, IN, NJ, VA, SD, CO, KY, AL, MO, LA, DE, MA, MT, WV, ID, CT, NV, NH, ME, WY, DC, RI, NM, VT and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Monaco, Netherlands, Norway, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Product description
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Code information (models, lots, serial numbers)
UDI-DI: 00886874112496, All Lots.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EndoWrist 470347Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,082 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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