FDA recall, , Moderate risk
eTRAX Needle Sensor and System Starter Kit
The eTRAX Needle System Starter Kit has an error in inspection and programming, potentially causing incorrect needle tip position on the interface.
Summary by Recall Canary from the FDA notice
What happened
Civco Medical Instruments Co. Inc. of Kalona, Iowa, is voluntarily recalling eTRAX Needle System Starter Kits and eTRAX Needle Sensors for Aurora trackers due to an error in inspection and programming. This error could cause the needle tip position to be incorrectly identified on the user interface. The recall began March 2, 2026, and was added to the FDA's Enforcement Report on April 1, 2026.
The recalled products include starter kits in 12G, 14G, 16G, and 18G, and needle sensors in 12G, 14G, 16G, and 18G. They were distributed in Ohio, Pennsylvania, Washington, and China.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
8 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- UDI-DI
- 00841436111065
- Lot code
- A233347
- A228677
- A268116
- A268238
- A272513
- A279457
- A280388
- A281840
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- UDI-DI
- 00841436111041
- Lot code
- A228673
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
- UDI-DI
- 00841436111089
- Lot code
- A276633
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- UDI-DI
- 00841436111102
- Lot code
- A257459
- A252198
- A268105
- A276632
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
- UDI-DI
- 00841436111058
- Lot code
- A228675
- A228676
- A233854
- A268115
- A268237
- A272509
- A277538
- A280341
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
- UDI-DI
- 00841436111096
- Lot code
- A276636
- A282454
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- UDI-DI
- 00841436111034
- Lot code
- A228672
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
- UDI-DI
- 00841436111072
- Lot code
- A276634
Recall details
- Company began the recall
- Sold in
US States: Ohio, Pennsylvania, Washington. China.
- Company
- Civco Medical Instruments Co. Inc.Kalona, Iowa
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98513
- Recall numbers
- Z-1731-2026 to Z-1738-2026
- Recall type
- Voluntary: Firm initiated
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
