Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BX2 Needle Guide Recalled by Civco Medical Instruments Co. Inc. Due to During the attachment of the needle guide to...

Date: May 1, 2025
Company: Civco Medical Instruments Co. Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Civco Medical Instruments Co. Inc. directly.

Affected Products

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

Quantity: 506 boxes

Why Was This 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.

Where Was This Sold?

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

About Civco Medical Instruments Co. Inc.

Civco Medical Instruments Co. Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report