Z-1943-2015Class II

Velocity" Biopsy Valve, 25 units per box

Name: Z-1943-2015 Velocity" Biopsy Valve, 25 units per box
Creator: US Endoscopy Group Inc
Published: 2015-02-17
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2015-02-17 / Terminated

FDA source

US Endoscopy Group Inc began a recall of 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... on 2015-02-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1943-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-17
Posted: 2015-07-01
Terminated: 2015-09-21
Recalling firm: United States Endoscopy Group, Inc.
Product: 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 code: OCX Endoscopic Irrigation/Suction System
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.
FDA root cause: Under Investigation by firm
Action: US Endoscopy sent an Urgent Recall Notification Letter dated to their customers. The letter identified the affected product, problem and actions to be taken. US Endoscopy requests that their customers: 1. Remove all unused affected Velocity Biopsy Valves from your inventory. 2. Complete the attached Customer Response Card and return to the attention of Kia Pennington, via fax 1-440-639-4495 or email [email protected]. 3. Mark the shipping container with code: RMA xxxxxxxx QIF, and return the product to US Endoscopy via Fed Ex Account #293799547. For questions contact Kia Pennington in Customer Service at 1-800-769-8226.
Quantity in commerce: 2,173 units
Distribution: 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.
Product codes and lots: M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-30

Product code OCX

K092461Class IIIrrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc. / cleared 2009-11-05

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)