Intuitive Surgical, Inc. 2023-12-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0406-2024
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm Recall
Issued December 6, 2023 · Intuitive Surgical, Inc.
In December 2023, Intuitive Surgical, Inc. recalled the Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
What you should do
- 1 Stop using Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm 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
- December 6, 2023
- Units affected
- Not reported
- Sold at
- US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
- Recall number
- FDA-Z-0406-2024
- 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 903rd Health recall we've logged in 2023.