FDA Device recall Z-0441-2015
8MM, LARGE HEM-O-LOK CLIP APPLIER
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of 8MM, LARGE HEM-O-LOK CLIP APPLIER by Intuitive Surgical.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-03 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | FL, IN, MA, NV, NY, OR, TX, UT |
Product
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason
Identifiers
| code_info | Part number; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. |
|---|
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-0441-2015%22
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