US Endoscopy Group Inc: Medical Device Recall in 2015 - (Recall #: Z-1943-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.

Product Classification:

Class II

Date Initiated: February 17, 2015

Date Posted: July 8, 2015

Recall Number: Z-1943-2015

Event ID: 71336

Reason for Recall:

The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.

Status: Terminated

Product Quantity: 2,173 units

Code Information:

M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated