da Vinci SP — Class II medical device recall Z-1096-2026
Ongoing recall by Intuitive Surgical, Inc., reported 2026-01-21, distributed nationwide. Access Port System tray may develop cracks potentially resulting in a sterility breach.
| Recall number | Z-1096-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2025-12-15 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CN, CZ, DE, DK, ES, FR, GB, GR, HK, IE, IT, JP, KR, PL, RO, SA, SE, TW |
| Quantity | 41,526 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00886874119549, 00886874119556 |
| Lot numbers | K10250113, K10250114, K10250305, K10250306, K10250313, K10250327, K10250403, K10250414, K10250424, K10250514, K10250515, K10250522, K10250529, K10250605, K10250619, K10250626, K10250629, K10250630, K10250701, K10250702, K10250710, K10250716, K10250717, K10250723, K10250731, K10250804, K10250806, K10250807, K10250828, K10250904, K11250113, K11250515, K11250529, K11250807, K11250813, K11250814, K11250821, K11250828, K11250911, K12250821 and 100 more |
| Model numbers | 430073, 430075 |
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Reason for recall
Access Port System tray may develop cracks potentially resulting in a sterility breach.
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-1096-2026. 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.