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 is recalling EndoWrist Suction Irrigators (Part Number 480299-04) because they might generate silicone particles during surgery that could enter patients. This is a serious risk for surgical procedures.
The device may generate silicone particles during irrigation. If these particles enter the patient's body, they could cause complications during surgery. This risk occurs when the device is used in endoscopic procedures.
Surgical teams using the EndoWrist Suction Irrigator during endoscopic procedures are affected. Patients undergoing surgery with this device are at risk of silicone particles entering their bodies.
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.
Immediately stop using the EndoWrist Suction Irrigator if it has Part Number 480299-04.
No, the device may generate silicone particles during surgery that could enter patients, so it should not be used.
Part Number 480299-04 (UDI 00886874114810) is affected.
Lots T10180226 and onward are affected.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0249-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0249-2020 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
