FDA Device recall Z-1118-2015
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000 by Intuitive Surgical, citing internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1118-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-21 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | PR |
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
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Identifiers
| code_info | PN 400275, 420275, and 420272. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2015%22
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