FDA Device recall Z-1210-2022
DAVINCI
- FDA Device
- Class II
- completed
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of DAVINCI 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-1210-2022 |
| 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
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
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: 00886874117309. 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-1210-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.