Intuitive Surgical recalls EndoWrist Suction Irrigator (Part 480299-04) due to potential silicone particle generation during surgery, which could enter patients. Affected units include specific lots and part numbers.
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
“Intuitive Surgical EndoWrist Suction Irrigator Recall: Silicone Particle Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70906-intuitive-surgical-endowrist-suction-irrigator-recall-silicone-particle-risk. Based on FDA recall #Z-0249-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0249-2020%22&limit=1).
The FDA announced on June 4, 2018, that Intuitive Surgical, Inc. is recalling EndoWrist Suction Irrigator single-use instruments due to the potential for silicone particles to be introduced into patients during surgery.
How to tell if you have it
Brand: Intuitive Surgical
Product: EndoWrist Suction Irrigator, Single Use Instrument
Part Number: 480299-04 (UDI 00886874114810)
Lots: T10180226 and onward
Quantity: 3108 units
The hazard
According to the FDA, the firm identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
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 Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), Medline medical procedure kits with Strykeflow 2 irrigation leak risk - recall (December 16, 2025), and Boston Scientific Orca Air/Water Valves Recall (May 12, 2026).
How to tell if you have this one
Check for Part Number 480299-04 on the device. Affected units were sold with Lots T10180226 and onward. This is an accessory to the EndoWrist Surgical System used in endoscopic surgery.
Brand
Intuitive Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the EndoWrist Suction Irrigator if it has Part Number 480299-04.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 17 months 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-0249-2020 (June 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0249-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 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.