Z-2381-2018 Class II Terminated
FDA device recall Z-2381-2018 was initiated by Intuitive Surgical, Inc. on Apr 23, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 15, 2020). Affected quantity: 6816.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2018
- Initiation Date
- Apr 23, 2018
- Termination Date
- Jul 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6816
Product Description
da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
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.
Distribution Pattern
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.
Code Information
UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2381-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026