Intuitive Surgical recalls da Vinci X/Xi 8mm single-use instruments due to risk of insufficient seal when excessive tissue is placed in jaws. Affected units have UDI 00886874117309.
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Intuitive Surgical is recalling certain da Vinci X and Xi surgical instruments because they can fail to seal properly if too much tissue is placed in the instrument jaws. This could lead to bleeding or other complications during surgery.
The instruments can create an insufficient seal when excessive tissue is placed in the jaws before sealing. This may cause bleeding or other complications during surgery if the seal fails.
Surgical teams using the recalled da Vinci X or Xi 8mm single-use instruments are affected. Surgeons and surgical staff who have used these instruments in procedures are most at risk.
Check for the UDI code 00886874117309 on the instrument. The product is the da Vinci X or Xi 8mm single-use instrument with reference number 480440.
Look for the UDI code 00886874117309 on the instrument to confirm it's affected.
Placing excessive tissue in the instrument jaws before sealing can result in an insufficient seal, potentially causing bleeding during surgery.
The recalled instrument has UDI code 00886874117309 and is the da Vinci X or Xi 8mm single-use instrument with reference number 480440.
No, but you should check if you have the recalled instrument and follow the instructions to verify if it's 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-1210-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-1210-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
