FDA Device recall Z-1191-2019
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Fl…
- FDA Device
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Fl… by Medrobotics, citing the weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1191-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-25 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medrobotics |
| Distribution | US |
Product
Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.
Reason
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Identifiers
| code_info | lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2019%22
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