Z-2396-2012Class II

Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH...

Name: Z-2396-2012 Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH...
Creator: US Endoscopy Group Inc
Published: 2011-12-22
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2011-12-22 / Terminated / root cause: manufacturing process

FDA source

US Endoscopy Group Inc began a recall of Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable... on 2011-12-22. FDA classified it as Class II and gives the reason as "US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2396-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-22
Posted: 2012-09-17
Terminated: 2013-03-22
Recalling firm: United States Endoscopy Group, Inc.
Product: 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 code: KOG
Reason for recall: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: US Endoscopy sent an Addendum and Correction to the Instructions for Use letter dated December 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to rinse the brush head with sterile water immediately prior to use (reference the attached Addendum. Customers were also instructed to retract and deploy the brush to ensure that is is functioning properly prior to use. Customers were asked to review the instruction for use for this product along with the Addendum to ensure proper usage and performance. For questions customers should call 1-410-639-4494 or their local Endoscopic Product Specialist. For questions regarding this recall call 440-639-4494, ext 378.
Quantity in commerce: 393 Devices
Distribution: 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.
Product codes and lots: Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2396-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2396-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code KOG

K103437Class IIUS Endoscopy Cytology BrushUnited States Endoscopy Group, Inc. / cleared 2010-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)