8MM — Class II medical device recall Z-0924-2025
Ongoing recall by Intuitive Surgical, Inc., reported 2025-01-22, distributed nationwide. Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
| Recall number | Z-0924-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2024-12-19 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, MT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, VE, VN, ZA |
| Quantity | 42,028 devices |
| UPC / GTIN / UDI-DI | 00886874112441 |
| Lot numbers | K10210921, K10210927, K10211004, K10211011, K10211018, K10211103, K10211108, K10211116, K10211117, K10211122, K10211206, K10211213, K10220217, K10220221, K10220228, K10220307, K10220314, K10220404, K10220425, K10220511, K10220516, K10220613, K10220725, K10220802, K10220808, K10220815, K10220912, K10220926, K10221016, K10221030, K10221102, K10221106, K10221113, K10221117, K10221118, K10230212, K10230219, K10230226, K10230420, K10230504 and 316 more |
| Model numbers | 470318 |
Product
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Reason for recall
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
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-0924-2025. 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.