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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Civco eTRAX Needle Sensors Recalled for Needle Tip Identification Error

Agency Publication Date: April 1, 2026
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Summary

Civco Medical Instruments Co. Inc. is recalling 87 units of eTRAX Needle Sensors and Starter Kits used with Aurora trackers. An error in the inspection and programming process can cause the needle tip's position to be incorrectly identified on the medical user interface. To ensure safety, healthcare providers and facilities should stop using the affected products immediately and contact Civco to arrange for a return or replacement.

Risk

The needle tip position may be displayed incorrectly on the screen during procedures, which could lead to inaccurate needle placement and potential injury to the patient. No specific injuries have been reported in this notice.

What You Should Do

  1. Stop using the recalled needle sensors and starter kits immediately.
  2. Check your inventory for the affected part numbers and lot numbers, including eTRAX Needle System Starter Kits (12G, 14G, 16G, 18G) and individual sensors. See the Affected Products section below for the full list of affected codes.
  3. Contact Civco Medical Instruments Co. Inc. or your distributor to arrange for a return, replacement, or correction of the device.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: eTRAX Needle System Starter Kit 12G (for Aurora Trackers)
Model / REF:
667-149
Lot Numbers:
A228672
UDI:
00841436111034

Recall #: Z-1731-2026

Product: eTRAX Needle System Starter Kit 14G (for Aurora Trackers)
Model / REF:
667-150
Lot Numbers:
A228673
UDI:
00841436111041

Recall #: Z-1732-2026

Product: eTRAX Needle System Starter Kit 16G(for Aurora Trackers)
Model / REF:
667-151
Lot Numbers:
A228675
A228676
A233854
A268115
A268237
A272509
A277538
A280341
UDI:
00841436111058

Recall #: Z-1733-2026

Product: eTRAX Needle System Starter Kit 18G (for Aurora Trackers)
Model / REF:
667-152
Lot Numbers:
A233347
A228677
A268116
A268238
A272513
A279457
A280388
A281840
UDI:
00841436111065

Recall #: Z-1734-2026

Product: eTRAX Needle Sensor - 12G (for Aurora Trackers)
Model / REF:
667-156
Lot Numbers:
A276634
UDI:
00841436111072

Recall #: Z-1735-2026

Product: eTRAX Needle Sensor - 14G(for Aurora Trackers)
Model / REF:
667-157
Lot Numbers:
A276633
UDI:
00841436111089

Recall #: Z-1736-2026

Product: eTRAX Needle Sensor - 16G(for Aurora Trackers)
Model / REF:
667-158
Lot Numbers:
A276636
A282454
UDI:
00841436111096

Recall #: Z-1737-2026

Product: eTRAX Needle Sensor - 18G (for Aurora Trackers)
Model / REF:
667-159
Lot Numbers:
A257459
A252198
A268105
A276632
UDI:
00841436111102

Recall #: Z-1738-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98513
Status: Active
Manufacturer: Civco Medical Instruments Co. Inc.
Sold By: Medical facilities; Specialty medical distributors
Manufactured In: United States
Units Affected: 8 products (2 units; 6 units; 18 units; 20 units; 5 units; 5 units; 10 units; 21 units)
Distributed To: Ohio, Pennsylvania, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.