EndoWrist recallZ-2380-2018 · Intuitive Surgical, Inc. · initiated Apr 23, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intuitive Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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).
Recall details
- Recall number
- Z-2380-2018
- Status
- Terminated
- Initiated by the company
- Apr 23, 2018
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 7337
- Product code
- GDW
- FDA submissions
- K140553
- 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 description
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Code information (models, lots, serial numbers)
UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EndoWrist 48645BIntuitive Surgical, Inc. · STAPLE, IMPLANTABLE1 recall1 death14 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 80318).
- Z-2381-2018 · Terminatedda Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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