DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi' — Class II medical device recall Z-1210-2022
Completed recall by Intuitive Surgical, Inc., reported 2022-06-08, distributed nationwide. Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in
| Recall number | Z-1210-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2022-03-03 |
| Classified | 2022-05-31 |
| Reported by FDA | 2022-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IT, JP, KR, LB, LU, MT, MX, MY, NL, NO, NZ, PA, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, VE, VN, ZA |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00886874117309 |
| Model numbers | 480440 |
Product
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Reason for recall
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1210-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.