Intuitive Surgical recalls 8MM Hem-O-LoK Clip Appliers with frayed or broken grip cables that could cause injury during surgery. Affected models include IS4000 with specific batch numbers.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical is recalling 8MM Hem-O-LoK Clip Appliers that have frayed or broken grip cables. This could lead to injury during surgical procedures if the instrument slips or malfunctions.
The grip cables on these instruments can fray or break during use, potentially causing the instrument to slip or malfunction. This could lead to injury if the instrument slips during surgery.
Surgical professionals using the recalled Hem-O-LoK Clip Appliers for procedures. Those with the specific batch numbers listed are most at risk.
Check the model number (470230) and batch numbers listed in the recall notice. The product includes a specific UDI-DI code (00886874112380) and part numbers.
Inspect the grip cables for fraying or breaks before use. If damaged, stop using the instrument immediately.
The affected models are the 8MM Hem-O-LoK Clip Applier IS4000 with model number 470230 and specific batch numbers listed in the recall notice.
Check the model number (470230) and batch numbers listed in the recall notice. The product includes a specific UDI-DI code (00886874112380) and part numbers.
The recall notice does not specify a return process or remedy, so you should check with Intuitive Surgical directly for further 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-0861-2025 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0861-2025 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.
