Z-2171-2014Class II

EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist...

Name: Z-2171-2014 EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist...
Creator: Intuitive Surgical, Inc.
Published: 2014-06-02
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-06-02 / Terminated / root cause: labeling and UDI

FDA source

Intuitive Surgical, Inc. began a recall of EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the... on 2014-06-02. FDA classified it as Class II and gives the reason as "Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for...". 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-2171-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Posted: 2014-08-08
Terminated: 2014-08-08
Recalling firm: Intuitive Surgical, Inc.
Product: EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Intuitive Surgical representatives hand delivered corrected manuals to the two affected sites..
Quantity in commerce: 2
Distribution: Distribution to Florida and South Carolina
Product codes and lots: Model number 410298-05 and 410298-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2171-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2171-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-08

Product code NAY

K113706Class IIEndowrist Stapler SystemIntuitive Surgical, Inc. / cleared 2012-10-17

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)