Intuitive Surgical, Inc. 2025-01-22 Health serious FDA
Health · FDA · Recall #FDA-Z-0849-2025
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 Recall
Issued January 22, 2025 · Intuitive Surgical, Inc.
In January 2025, Intuitive Surgical, Inc. recalled the 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
What you should do
- 1 Stop using 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Intuitive Surgical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Intuitive Surgical, Inc.
- Category
- Health
- Recall date
- January 22, 2025
- Units affected
- Not reported
- Sold at
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia,
- Recall number
- FDA-Z-0849-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Intuitive Surgical, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.