FDA Medical Device Recalls (openFDA)
US Endoscopy Group Inc: 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.
- Recall number
- Z-1943-2015
- Recalling firm
- US 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.
- Status
- Terminated
- Initiated
- 2015-02-17
- Posted
- 2015-07-01
- Terminated
- 2015-09-21
- Reason
- 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.
- 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 kpenning@usendoscopy.com. 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
- 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.
- Lot, serial or model codes
- M/N: 00711140; Lot #'s: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.
- 510(k) numbers
- ["K092461"]
- PMA numbers
- not on file
- Product code
- OCX
- Firm FEI
- 1000122656
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28