Intuitive Surgical recalls 8MM FENESTRATED BIPOLAR FORCEPS model IS4000 with specific batch numbers due to frayed or broken grip cables that could cause injury during surgery.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM fenestrated bipolar forceps (model IS4000) with certain batch numbers because frayed or broken grip cables could lead to injury during surgical procedures. This affects medical devices used by surgeons.
The grip cables on these reusable surgical instruments can become frayed or broken, which may cause the forceps to malfunction during surgery. This could potentially lead to injury to the patient or the surgeon if the instrument slips or fails unexpectedly.
Surgeons and medical professionals who use these bipolar forceps during surgery are most at risk. The recall applies to specific batch numbers of the IS4000 model.
Check the batch numbers listed in the recall: K10221106, K10221128, K10221204, and other specific codes provided in the recall notice. The product is labeled as 8MM fenestrated bipolar forceps, model IS4000.
Identify if your forceps have any of the listed batch numbers (e.g., K10221106, K10221128, etc.) from the recall notice.
The recall is due to increased complaints about frayed or broken grip cables on reusable instruments with jaws, which could cause injury during surgery.
Check the batch numbers on your forceps against the list provided in the recall notice. If your batch number is listed, you should stop using them until you can get a replacement.
Yes, the affected models are 8MM fenestrated bipolar forceps with the IS4000 model and specific batch numbers listed in the recall notice.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0878-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0878-2025 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.
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.
