Class II — Potential Health Hazard

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

Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters Recalled by STERILMED, INC. Due to Sterilmed, a division of Johnson & Johnson Medical...

Date: September 24, 2014
Company: STERILMED, 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 STERILMED, INC. directly.

Affected Products

Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.

Quantity: 22

Why Was This Recalled?

Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne

Where Was This Sold?

This product was distributed to 2 states: CA, WA

Affected (2 states)Not affected

About STERILMED, INC.

STERILMED, INC. has 4 total recalls tracked by RecallDetector.

Related Recalls

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