HARMONIC ACE Curved Shears Instructions for Use — Class II medical device recall Z-1118-2015
Terminated recall by Intuitive Surgical, Inc., reported 2015-02-25, distributed in PR. Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manu
| Recall number | Z-1118-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2015-01-21 |
| Classified | 2015-02-13 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-06-01 |
| Distributed | PR |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DO, EC, ES, FI, FR, GB, IL, IN, IT, JP, KR, LB, MX, NL, PA, PK, QA, RO, SA, SE, SG, SK, TH, TR, TW |
| Quantity | 12,467 |
| Reason classes | labeling |
Product
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Reason for recall
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
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-1118-2015. 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.