Civco Medical Instruments Co. Inc.: Medical Device Recall in 2025 - (Recall #: Z-1892-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 1, 2025

Date Posted: June 11, 2025

Recall Number: Z-1892-2025

Event ID: 96814

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.

Status: Ongoing

Product Quantity: 506 boxes

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated