8MM MONOPOLAR CURVED SCISSORS — Class II medical device recall Z-0434-2015
Terminated recall by Intuitive Surgical, Inc., reported 2014-12-03, distributed in FL, IN, MA, NV, NY, OR, TX, UT. Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradat
| Recall number | Z-0434-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2014-11-03 |
| Classified | 2014-11-25 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-02-03 |
| Distributed | FL, IN, MA, NV, NY, OR, TX, UT |
| Quantity | 509 units |
| Reason classes | specification failure |
| Model numbers | 470179-04, 8MM |
Product
8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason for recall
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
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-0434-2015. 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.