Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

BX2 Needle Guide Recalled for Risk of Transducer Cover Breach

Agency Publication Date: May 30, 2025
Share:
Sign in to monitor this recall

Summary

Civco Medical Instruments Co. Inc. has recalled 506 boxes of the BX2 Needle Guide, specifically Part Number 644-094. This tool is used during ultrasound procedures to guide needles or catheters. The recall was issued because the needle guide fits too tightly on the ultrasound probe, which can cause a tiny pinhole to form in the protective transducer cover when the guide is latched into place. No incidents or injuries have been reported to date.

Risk

A pinhole breach in the ultrasound transducer cover compromises the sterile barrier between the patient and the medical equipment. This defect can lead to potential patient infection or cross-contamination during medical procedures.

What You Should Do

  1. This recall affects BX2 Needle Guides, Part Number 644-094, used for ultrasound-guided procedures (UDI-DI 00841436120050).
  2. Check the device label or packaging for the Part Number and Lot Number to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately. Contact Civco Medical Instruments Co. Inc. or your authorized medical device distributor to arrange for the return, replacement, or correction of the device.
  4. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BX2 Needle Guide
Model / REF:
644-094
Lot Numbers (75):
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
UDI:
00841436120050

Recall Number: Z-1892-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96814
Status: Active
Manufacturer: Civco Medical Instruments Co. Inc.
Sold By: Authorized medical device distributors
Manufactured In: United States
Units Affected: 506 boxes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.