da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi… — Class II medical device recall Z-0999-2022
Ongoing recall by Intuitive Surgical, Inc., reported 2022-05-04, distributed nationwide. As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureF
| Recall number | Z-0999-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2022-03-17 |
| Classified | 2022-04-22 |
| Reported by FDA | 2022-05-04 |
| 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, MY, NL, NO, NZ, PA, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| UPC / GTIN / UDI-DI | 00886874115640, 00886874117583, 00886874117590 |
| Model numbers | 480445, 480460, 480545 |
Product
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
Reason for recall
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.
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-0999-2022. 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.