Class II

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

Civco Medical Instruments Co. Inc. · May 1, 2025

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.

Distribution

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

Quantity Affected

506 boxes

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1892-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Civco Medical Instruments Co. Inc. Medical Device Recall: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers | SafeCheck