FDA Device recall Z-1465-2023
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
- FDA Device
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS by Covidien, citing there is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1465-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-22 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Reason
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Identifiers
| code_info | UDI-DI: 10884521784062; Serial Numbers: C21RXG0005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1465-2023%22
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