US Endoscopy Group Inc: Medical Device Recall in 2014 - (Recall #: Z-0861-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 31, 2014

Date Posted: December 31, 2014

Recall Number: Z-0861-2015

Event ID: 69809

Reason for Recall:

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

Status: Terminated

Product Quantity: 100 units

Code Information:

Lot 1417696

Distribution Pattern:

Distributed to the states of FL, MO, OH and WI.

Voluntary or Mandated:

Voluntary: Firm initiated