CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report

BX2 Needle Guide recalled by Civco Medical Instruments Co

Civco Medical Instruments is recalling BX2 Needle Guide, distributed in Georgia. The recall was initiated on 1 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607

Quantity recalled506 boxes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1892-2025
FDA event ID: 96814
Recalling firm: Civco Medical Instruments, Kalona, IA
Classification: Class II
Status: Ongoing
Recall initiated: 1 May 2025
FDA classified: 30 May 2025
Reported: 11 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

1 May 2025	Recall initiated by company
30 May 2025	Classified by FDA	+29 days
11 Jun 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

Product as listed by the FDA

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

Where it was distributed

OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

Georgia

Questions about this recall

Why was it recalled?

During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

Which lots are affected?

UDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607

Where was it sold?

OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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8 Apr 2026Device	CLASS II	eTRAX Needle Sensor - (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle System Starter Kit (for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA
8 Apr 2026Device	CLASS II	eTRAX Needle Sensor -(for Aurora Trackers) recalled	Civco Medical Instruments	Processing Deviation	OH, PA, WA

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