Class II — Potential Health Hazard

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

27023WU Balloon Catheter Recalled by Karl Storz Endoscopy America Inc Due to Karl Storz Endoscopy-America has initiated the recall of...

Date: May 31, 2013
Company: Karl Storz Endoscopy America 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 Karl Storz Endoscopy America Inc directly.

Affected Products

27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.

Quantity: 40 units

Why Was This Recalled?

Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.

Where Was This Sold?

This product was distributed to 5 states: AZ, FL, IL, IN, TX

Affected (5 states)Not affected

About Karl Storz Endoscopy America Inc

Karl Storz Endoscopy America Inc has 17 total recalls tracked by RecallDetector.

Related Recalls

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