Severity
Moderate
FDA Devices recall · Reported April 8, 2026
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…
The recall
Civco Medical Instruments Co. Inc. issued this moderate-severity FDA Devices recall — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result i….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1733-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1733-2026) was formally reported on April 8, 2026, with the manufacturer initiating the action on March 2, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Civco Medical Instruments Co. Inc. is listed as the recalling firm, operating out of Kalona, IA. Federal records list the affected scope as 18 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US States: OH, PA, WA. China.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Severity
Moderate
Affected scope
18 units
Related Recalls
6
6 from same agency
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1733-2026 |
| Date reported | April 8, 2026 |
| Date initiated | March 2, 2026 |
| Recalling firm | Civco Medical Instruments Co. Inc. |
| Firm location | Kalona, IA |
| Affected scope | 18 units |
| Distribution | US States: OH, PA, WA. China. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 8, 2026.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.