VirtuTRAX Instrument Navigator — Class II medical device recall Z-0396-2022
Terminated recall by Civco Medical Instruments Co. Inc., reported 2021-12-29, distributed nationwide. There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
| Recall number | Z-0396-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Civco Medical Instruments Co. Inc., Kalona, IA, United States |
| Recall initiated | 2021-10-08 |
| Classified | 2021-12-20 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CN, DE, DK, ES, FR, IT, JP, KR, NL, SG, TH, TW |
| UPC / GTIN / UDI-DI | 00841436102285 |
| Lot numbers | A122182, A131167, A131689, A131691, A141823 |
| Model numbers | 610-1153 |
Product
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Reason for recall
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
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-0396-2022. 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.