Da Vinci Single-Site Wristed Needle Driver recall
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Why was Da Vinci Single-Site Wristed Needle Driver recalled?
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109
- Product
- Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 317 units
- Distribution
- US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
- Recall date
- December 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)