US Endoscopy Group Inc: Medical Device Recall in 2012 - (Recall #: Z-2396-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.

Product Classification:

Class II

Date Initiated: December 22, 2011

Date Posted: September 26, 2012

Recall Number: Z-2396-2012

Event ID: 63047

Reason for Recall:

US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

Status: Terminated

Product Quantity: 393 Devices

Code Information:

Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

Distribution Pattern:

Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated