Class II — Potential Health Hazard

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

HSG Trays/HS 5F Catheter Combo Recalled by Catheter Research, Inc Due to Mislabeling

Date: April 7, 2015
Company: Catheter Research, Inc
Status: Terminated
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 Catheter Research, Inc directly.

Affected Products

HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.

Quantity: 880 units

Why Was This Recalled?

HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

Where Was This Sold?

This product was distributed to 8 states: CA, FL, IL, MA, MN, OH, VA, WI

Affected (8 states)Not affected

About Catheter Research, Inc

Catheter Research, Inc has 1 total recall tracked by RecallDetector.

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