Intuitive Surgical recalls 8MM MEGA SUTURECUT ND IS4000 surgical instruments with frayed or broken grip cables that could cause injury during use. Affected units have specific model and batch numbers.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM MEGA SUTURECUT ND IS4000 surgical instruments due to frayed or broken grip cables. This could lead to injury if the instrument slips during surgery.
The grip cables on these instruments can fray or break during use, causing the instrument to slip. This could lead to injury if the instrument slips during surgery.
Surgical professionals and hospitals using the affected 8MM MEGA SUTURECUT ND IS4000 instruments. Those handling the instruments during procedures are at risk of injury if the grip cable fails.
Check for model number 471309 with specific batch numbers listed in the recall notice. The instruments have a UDI-DI code starting with 00886874119815.
Look for model number 471309 on the instrument with the listed batch numbers.
If you find frayed or broken grip cables, stop using the instrument immediately.
The affected batch numbers include K10221113, K10221115, K10221212, and many others listed in the recall notice.
Check for model number 471309 with the specific batch numbers listed in the recall notice, which start with K or U followed by 10 digits.
The recall notice does not specify a return process, so contact Intuitive Surgical directly for instructions.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0880-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0880-2025 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.
