Z-1837-2016Class II

SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380...

Name: Z-1837-2016 SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380...
Creator: Intuitive Surgical, Inc.
Published: 2016-05-09
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-05-09 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is... on 2016-05-09. FDA classified it as Class II and gives the reason as "Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1837-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-05-27
Terminated: 2016-11-01
Recalling firm: Intuitive Surgical, Inc.
Product: SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Upon discovery of the issue, Intuitive sent Urgent Product Safety Notices to all customers by e-mail to initially alert them of the situation. This will be followed by a formal letter that is scheduled to arrive on May 23, 2016. Both notification request that users Do NOT use the da Vinci Xi 5 mm8 mm Universal Cannula Seal or the da Vinci Xi 12 mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during intracardiac procedures.
Quantity in commerce: 46,191 boxes total - both sizes
Distribution: Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1837-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1836-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-27
Z-1837-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-27

Product code NAY

K140553Class IIEndowrist Stapler 45 and Stapler 45 ReloadsIntuitive Surgical, Inc. / cleared 2014-07-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)