8MM — Class II medical device recall Z-0856-2025
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-0856-2025 |
|---|---|
| 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 | 7,132 |
| UPC / GTIN / UDI-DI | 00886874112281 |
| Lot numbers | K10221204, K10230219, K10230226, K10230302, K10230310, K10230427, K10230518, K10230525, K10230601, K10230608, K10230615, K10230622, K10230629, K10230913, K10231019, K10231123, K10240222, K10240327, K10240404, K10240418, K10240425, K10240502, K10240711, K11231019, K11231116, K11240502, K11240711 |
| Model numbers | 470172, 470172-17 |
Product
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
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-0856-2025. 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.