FDA Medical Device Recalls (openFDA)
US Endoscopy Group Inc: Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
- Recall number
- Z-0001-2016
- Recalling firm
- US Endoscopy Group Inc
- Product
- Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
- Status
- Terminated
- Initiated
- 2015-07-14
- Posted
- 2015-10-01
- Terminated
- 2016-10-27
- Reason
- The company has determined the sterility cannot be assured for the affected lot.
- Root cause
- Employee error
- Action
- The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com.
- Quantity
- 41 units
- Distribution
- US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
- Lot, serial or model codes
- M/N: 00711117; Lot #: 1505956
- 510(k) numbers
- ["K140763"]
- PMA numbers
- not on file
- Product code
- FDI
- 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