FDA-Device2023-12-06Class II
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical, Inc.
Hazard
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
Sold states
US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea
Affected count
317 units
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0406-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief