8MM — Class II medical device recall Z-0858-2025
Ongoing recall by Intuitive Surgical, Inc., reported 2025-01-22, distributed nationwide. Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
| Recall number | Z-0858-2025 |
|---|---|
| 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 | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KR, KW, KY, 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 | 38,438 |
| UPC / GTIN / UDI-DI | 00886874112342 |
| Lot numbers | K10221113, K10221128, K10221204, K10221212, K10221218, K10230112, K10230205, K10230212, K10230217, K10230302, K10230310, K10230316, K10230323, K10230405, K10230420, K10230511, K10230525, K10230601, K10230608, K10230615, K10230622, K10230706, K10230713, K10230720, K10230727, K10230810, K10230817, K10230824, K10230907, K10230914, K10230921, K10230928, K10231012, K10231019, K10231027, K10231102, K10231109, K10231123, K10231130, K10231207 and 55 more |
| Model numbers | 470194, 470194-06, 470194-08 |
Product
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Reason for recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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-0858-2025. 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.