Z-1210-2022 Class II
FDA device recall Z-1210-2022 was initiated by Intuitive Surgical, Inc. on Mar 3, 2022 and is designated Class II. Reason for recall: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. Affected quantity: 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user…
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- Mar 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1210-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026