- Recalling firm
- Civco Medical Instruments Co. Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
- Units affected
- 18 units
- Distribution pattern
- US States: OH, PA, WA. China.
- Firm location
- Kalona, IA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1733-2026
- Recall initiated
- March 2, 2026
- FDA classification date
- April 1, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98513
- Last updated on HTM Vibe
- July 24, 2026