Civco Medical Instruments Co. Inc. recalls BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagn…

Recall date

May 1, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1892-2025

FDA classification

Class II

Brand / firm

Civco Medical Instruments Co. Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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