Z-1099-2013Class II

Torrent" irrigation tubing

Name: Z-1099-2013 Torrent" irrigation tubing
Creator: US Endoscopy Group Inc
Published: 2013-03-07
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2013-03-07 / Terminated / root cause: design

FDA source

US Endoscopy Group Inc began a recall of Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is... on 2013-03-07. FDA classified it as Class II and gives the reason as "The firm was notified by their customers that there was a water leakage from the white tubing connector". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1099-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Posted: 2013-04-11
Terminated: 2014-03-20
Recalling firm: United States Endoscopy Group, Inc.
Product: Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
Product code: OCX Endoscopic Irrigation/Suction System
Reason for recall: The firm was notified by their customers that there was a water leakage from the white tubing connector.
Root cause tag: design
FDA root cause: Device Design
Action: US Endoscopy Group sent an Urgent Recall Notification letters to their customers. The letter identified the affected product, problem and actions to be taken. They instructed their customers to remove any of the affected products from their inventory and quarantine them. They also requested each customer complete the attached Customer Response Card and return it to US Endoscopy via fax at 1-440-639-4495 or by email at [email protected] as soon as possible. For questions contact Customer Service at 1-800-769-8229.
Quantity in commerce: 21,189 units
Distribution: USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.
Product codes and lots: Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81991, 82567, 82568, 82569, 82570, 82938, 82939, 82940, 82941, 82942, 82943, 82944, 82945, 82946, 82947, 82948, 82949, 82950, 82951, 82953, 82954, 82955, 82956, 84615, 84616, 84617, 84618, 84619, 84620, 84979, 84981, 85557, 86026, 86028, 86434, 86435 & 86436.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-17	2013-04-11

Product code OCX

K103239Class IIIrrigation SystemUnited States Endoscopy Group, Inc. / cleared 2010-12-30

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)