Class II — Civco Medical Instruments Co. Inc.
| Recalling firm | CIVCO Medical Instruments Co., Inc. |
|---|---|
| Registered facility | CIVCO Medical Instruments Co., Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
| Product | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX |
| Quantity | 18 boxes (5 units/box) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand. |
| Initiated | 2021-10-08 |
| Classified | 2021-12-20 |
| Terminated | 2024-09-30 |
| Recall number | Z-0397-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Civco Medical Instruments Co. Inc. (Z-0397-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88906/
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