FDA Device recall Z-0437-2015
8MM PERMANENT CAUTERY SPATULA
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of 8MM PERMANENT CAUTERY SPATULA by Intuitive Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0437-2015 |
| 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 PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Reason
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.
Identifiers
| code_info | Part number 470184-04; 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-0437-2015%22
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