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 | Ongoing |
| Reason | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. |
| Product | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 |
| Quantity | 18 units |
| Distribution | US States: OH, PA, WA. China. |
| Initiated | 2026-03-02 |
| Classified | 2026-04-01 |
| Recall number | Z-1733-2026 |
| 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-1733-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98513/
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