Civco eTRAX 18G needle sensor may misreport needle tip position
Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the displayed needle tip position may not match the actual position during a guided procedure, and no injuries are stated.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle Sensor 18G for Aurora Trackers, part number 667-159. About 21 units were distributed in Ohio, Pennsylvania and Washington, and to China. The FDA has classified this recall as Class II.
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 product carries UDI-DI 00841436111102, across lots A257459, A252198, A268105 and A276632.
Facilities can identify affected sensors by the part number, UDI and lot numbers above, and may contact Civco Medical Instruments Co. Inc. for further information.
The recalled product
- Product
- eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00841436111102
- Lot Number: A257459
- A252198
- A268105
- A276632
Distribution
Part of a larger recall action
This product is one of 8 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Civco Medical Instruments Co. Inc.
See all →- HighCivco eTRAX 12G starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX needle sensor may misreport needle tip position onscreen
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 14G starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX needle starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 18G starter kit may misreport needle tip position
FDA (Devices) · 2026-04-08
Same hazard · position error
See all →- HighCivco eTRAX 14G needle sensor may misreport needle tip position
FDA (Devices) · 2026-04-08
- HighCivco eTRAX 12G needle sensor may misreport needle tip position
FDA (Devices) · 2026-04-08
Similar recalls
- HighVirtuTRAX Instrument Navigator Sensor May Fail to Tighten Properly
FDA (Devices) · 2021-12-29
- HighCivco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
FDA (Devices) · 2012-07-18
- HighCivco Needle Guide Recall Due to Missing or Inadequate Adhesive
FDA (Devices) · 2018-09-05
- HighCIVCO General Purpose Sensor Recalled for Calibration Errors
FDA (Devices) · 2012-07-18
- HighVirtuTRAX Instrument Navigator Sensor May Fail to Tighten
FDA (Devices) · 2021-12-29
- ModerateBX2 Needle Guide may develop transducer cover breach during attachment
FDA (Devices) · 2025-06-11