Class II — Potential Health Hazard

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

UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging Recalled by US Endoscopy Group Inc Due to Packaging non-conformance related to the integrity of the...

Date: October 31, 2014
Company: US Endoscopy Group 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 US Endoscopy Group Inc directly.

Affected Products

UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

Quantity: 100 units

Why Was This Recalled?

Packaging non-conformance related to the integrity of the sterile pouch seal.

Where Was This Sold?

This product was distributed to 4 states: FL, MO, OH, WI

Affected (4 states)Not affected

About US Endoscopy Group Inc

US Endoscopy Group Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

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