Intuitive Surgical 8MM Tenaculum Forceps IS4000 Recall: Frayed Grip Cables Risk Injury

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Contact the company & request your remedy

Recalling firmIntuitive Surgical, Inc.1266 Kifer Rd · Sunnyvale, CA 94086-5304

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Intuitive Surgical is recalling 8MM Tenaculum Forceps IS4000 models with specific batch numbers because frayed or broken grip cables could lead to injury. This recall affects surgical instruments used by healthcare professionals and requires immediate attention to prevent potential harm.

Why it’s dangerous

Frayed or broken grip cables on these reusable surgical instruments could cause the instrument to slip or malfunction during use, potentially leading to injury to the user or patient. This hazard occurs when the instrument is handled without proper cable integrity.

Who’s affected

Healthcare professionals using these surgical instruments are most at risk. The recall applies to specific batch numbers of the 8MM Tenaculum Forceps IS4000 models.

How to tell if you have this one

Check for batch numbers K10221218 through K11240822 on the instrument's label. The product is an 8MM Tenaculum Forceps IS4000 model with the part number 470207-10.

Brand
Intuitive Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Frayed Cables
Inspect the grip cable for fraying or breaks before use. If damaged, stop using the instrument immediately.
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on safe handling or replacement options.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

Due to increased complaints about frayed or broken grip cables on reusable surgical instruments with jaws.

What batch numbers are affected?

Batch numbers K10221218 through K11240822.

How can I tell if I have the recalled product?

Look for the batch numbers K10221218 to K11240822 on the instrument's label. The product is an 8MM Tenaculum Forceps IS4000 model with part number 470207-10.

Take action

Contact Intuitive Surgical

We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0860-2025 — Intuitive Surgical Intuitive Surgical

Hello,

I own a Intuitive Surgical that is covered by recall Z-0860-2025 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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Where this comes from

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.

Official source: FDA Recall #Z-0860-2025 (December 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0860-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Intuitive Surgical, Inc. recalls 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207

Use caution until it’s fixed