Lower riskMedical device recall · FDA · Published April 23, 2018
Intuitive Surgical da Vinci Xi Stapler 45 Reloads May Have Missing Knife Component
Intuitive Surgical recalls da Vinci Xi EndoWrist Stapler 45 Reload Green (Model 48445G-03) due to potential missing knife component causing failure to cut tissue. Affected units sold until 2020.
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.
Intuitive Surgical is recalling da Vinci Xi EndoWrist Stapler 45 Reload Green units (Model 48445G-03) because they may be missing a knife component. This could prevent the stapler from cutting tissue properly when fired. The recall affects units sold until 2020. Read more at govinfonow.com/recall/71351-intuitive-surgical-da-vinci-xi-stapler-45-reloads-may-have.
“Intuitive Surgical da Vinci Xi Stapler 45 Reloads May Have Missing Knife Component.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71351-intuitive-surgical-da-vinci-xi-stapler-45-reloads-may-have. Based on FDA recall #Z-2381-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2381-2018%22&limit=1).
The FDA announced on April 23, 2018, that Intuitive Surgical, Inc. voluntarily recalled the da Vinci Xi EndoWrist Stapler 45 Reload Green (Model 48445G-03) due to a potential missing knife mechanism component. This defect may prevent the device from cutting tissue when fired.
How to tell if you have it
Brand: Intuitive Surgical
Product: da Vinci Xi EndoWrist Stapler 45 Reload Green
Model: 48445G-03
Quantity: 12 reloads/box
UDI: 00886874112823
Expiration dates: 10/14/2017 through 02/21/2020
Units affected: 6,816
The hazard
The recall addresses an issue where the da Vinci Xi Stapler 45 Blue and Green Reloads may be missing a component of the knife mechanism. Without this part, the reload knife will not move or cut tissue when the stapler is fired.
Context
GovInfoNow's records show Intuitive Surgical, Inc. has had 53 other recalls on record since June 1, 2017. Recent recalls of similar products include the Da Vinci 5 dV5 Tower NIR Handheld Camera Recall (April 24, 2026), the Intuitive Surgical Da Vinci Surgical System Recall (April 22, 2026), and the Da Vinci X and Xi Surgical Systems Recall (April 2, 2026). Other recent recalls of similar products include the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), the Charlotte Claw Screw Recall (August 18, 2026), and the Kii Low Profile Bladed Dual Pack Recall (December 11, 2025).
How to tell if you have this one
Check for the model number 48445G-03 on the product packaging. The product was sold with a device expiration date of 10/14/2017 and 02/21/2020.
Brand
Intuitive Surgical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-2380-2018
da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.; UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020
7337
Z-2381-2018
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.; UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
6816
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number on the packaging to confirm if it matches 48445G-03.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2381-2018 (April 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2381-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.