FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086
- Recall number
- Z-0658-2008
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,
- Status
- Terminated
- Initiated
- 2007-03-09
- Posted
- 2008-01-31
- Terminated
- 2011-04-19
- Reason
- Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
- Root cause
- Nonconforming Material/Component
- Action
- The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.
- Quantity
- 206 units
- Distribution
- Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.
- Lot, serial or model codes
- Part #420004-01, Lot Numbers: SA054702, SA060504, SA062801, and SA062104
- 510(k) numbers
- ["K050369"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28