Use cautionMedical device recall · FDA · Published June 12, 2023
Intuitive Surgical da Vinci Xi/X Tip-Up Grasper Recall: Risk of Stainless Steel Fragments
Intuitive Surgical recalls da Vinci Xi/X Tip-Up Fenestrated Graspers with potential for stainless steel fragments to fall into patients during surgery.
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.
“Intuitive Surgical da Vinci Xi/X Tip-Up Grasper Recall: Risk of Stainless Steel Fragments.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57860-intuitive-surgical-da-vinci-xi-x-tip-up-grasper-recall. Based on FDA recall #Z-2059-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2023%22&limit=1).
The FDA announced on June 12, 2023, that Intuitive Surgical, Inc. is recalling da Vinci Xi/X Tip-Up Fenestrated Graspers due to a manufacturing issue causing potential breakage and patient exposure to stainless steel fragments. The agency issued recall number Z-2059-2023 for the Class II device.
How to tell if you have it
Brand: Intuitive Surgical
Product: da Vinci Xi/X Tip-Up Fenestrated Grasper
REF: 470347
VER: 12
UDI-DI: 00886874112496
All Lots
The hazard
According to the FDA, the fenestrated graspers have a manufacturing issue that has the potential to cause breakage on both upper and/or lower grips. This could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has 53 other recalls on record since June 1, 2017. Other recent recalls of similar products include Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and Da Vinci X and Xi Surgical Systems Recall (April 2, 2026). Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (December 4, 2025), Merit Medical Vascular Tray Recall (December 4, 2025), and Olympus HX-400U-30 Ligating Device Recall (October 30, 2025).
How to tell if you have this one
Check for the product name 'da Vinci Xi/X Tip-Up Fenestrated Grasper', reference number 470347, and version 12. All lots are affected.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the reference number 470347 and version 12 on the grasper.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2059-2023 (June 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2059-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.