Obturator — Class II medical device recall Z-1192-2019
Terminated recall by Medrobotics Corporation, reported 2019-04-24, distributed nationwide. The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
| Recall number | Z-1192-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medrobotics Corporation, Raynham, MA, United States |
| Recall initiated | 2019-01-25 |
| Classified | 2019-04-17 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, IT |
| Quantity | 24 |
| Reason classes | device malfunction |
| Lot numbers | 19419-01, 19669-06, 19684-06 |
| Model numbers | 26114 |
Product
Obturator (shortcone), Part number 26114 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 for recall
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1192-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.