FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, Sunnyvale, CA
- Recall number
- Z-0669-2008
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, Sunnyvale, CA
- Status
- Terminated
- Initiated
- 2007-11-19
- Posted
- 2008-01-31
- Terminated
- 2008-08-27
- Reason
- Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
- Root cause
- Other
- Action
- On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Quantity
- 89 units
- Distribution
- Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
- Lot, serial or model codes
- Lot Numbers Affected: SA070902, SA071101, and SA071401
- 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