Intuitive Surgical, Inc. Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA
Brand
Intuitive Surgical, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
Products Sold
Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
Intuitive Surgical, Inc. is recalling Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS20 due to (1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling l. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
(1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.
Recommended Action
Per FDA guidance
On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026