Z-2380-2018Class II

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box

Name: Z-2380-2018 da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box
Creator: Intuitive Surgical, Inc.
Published: 2018-04-23
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2018-04-23 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box on 2018-04-23. FDA classified it as Class II and gives the reason as "Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload...". 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-2380-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-23
Posted: 2018-07-06
Terminated: 2020-07-15
Recalling firm: Intuitive Surgical, Inc.
Product: da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Product code: GDW Staple, Implantable
Reason for recall: Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: "North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected]. "Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8AM to 6 PM CET) or [email protected] "South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) "Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST).
Quantity in commerce: 7337
Distribution: U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Product codes and lots: UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2380-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2380-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06
Z-2381-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-06

Product code GDW

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)