Z-0001-2016Class II

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically...

Name: Z-0001-2016 Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically...
Creator: US Endoscopy Group Inc
Published: 2015-07-14
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2015-07-14 / Terminated / root cause: manufacturing process

FDA source

US Endoscopy Group Inc began a recall of Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during... on 2015-07-14. FDA classified it as Class II and gives the reason as "The company has determined the sterility cannot be assured for the affected lot". 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-0001-2016
Classification: Class II
Status: Terminated
Initiated: 2015-07-14
Posted: 2015-10-01
Terminated: 2016-10-27
Recalling firm: United States 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.
Product code: FDI Snare, Flexible
Reason for recall: The company has determined the sterility cannot be assured for the affected lot.
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 41 units
Distribution: US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Product codes and lots: M/N: 00711117; Lot #: 1505956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0001-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-10-01

Product code FDI

K140763Class IIMonofilament Polypectomy SnareUnited States Endoscopy / cleared 2014-04-24

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)