FDA Device recall Z-1209-2022
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
- FDA Device
- Class II
- completed
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422 by Intuitive Surgical, citing placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1209-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-03-03 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Reason
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Identifiers
| code_info | UDI: 00886874115664. All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1209-2022%22
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