FDA Medical devices recall ·
eTRAX Needle System Starter Kit 18G (for Aurora Trackers)… recall
- Recall number
- Z-1734-2026
- Date
- (initiated March 2, 2026)
- Company / brand
- Civco Medical Instruments Co. Inc.
102 1st St S, Kalona, IA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840
Distribution
US States: OH, PA, WA. China.
States: Ohio Pennsylvania Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1734-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.