Z-1428-2013Class II

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument

Name: Z-1428-2013 Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument
Creator: Intuitive Surgical, Inc.
Published: 2011-09-19
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2011-09-19 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument on 2011-09-19. FDA classified it as Class II and gives the reason as "Clarification of existing labeling information and operating procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1428-2013
Classification: Class II
Status: Terminated
Initiated: 2011-09-19
Posted: 2013-05-29
Terminated: 2013-05-30
Recalling firm: Intuitive Surgical, Inc.
Product: Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Clarification of existing labeling information and operating procedures.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.
Quantity in commerce: NA
Distribution: Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Product codes and lots: Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1428-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1427-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1428-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29
Z-1429-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-29

Product code NAY

K050369Class IIIntuitive Surgical Da Vinci Surgical System, Model Is2000Intuitive Surgical, Inc. / cleared 2005-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)