da Vinci Xi/X Tip-Up Fenestrated Grasper — Class II medical device recall Z-2059-2023
Ongoing recall by Intuitive Surgical, Inc., reported 2023-07-12, distributed nationwide. Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower
| Recall number | Z-2059-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-06-30 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IT, JP, KR, KY, LU, MX, NL, NO, PL, PT, QA, RO, SA, SE, SG, SI, TR, TW, ZA |
| Quantity | 46,033 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00886874112496 |
| Model numbers | 470347 |
Product
da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Reason for recall
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
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-2059-2023. 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.