FDA Device recall Z-0432-2015
8MM,PROGRASP FORCEPS
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of 8MM,PROGRASP FORCEPS 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-0432-2015 |
| 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,PROGRASP FORCEPS; 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: 470093-04 ; 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-0432-2015%22
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