FDA Device recall Z-0001-2016
Histolock Resection Device, US Endoscopy
- FDA Device
- Class II
- terminated
- Published 2015-10-07
On 2015-10-07 the FDA classified a Class II recall of Histolock Resection Device, US Endoscopy by Us Endoscopy Group, citing the company has determined the sterility cannot be assured for the affected lot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0001-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-14 |
| Published | 2015-10-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Us Endoscopy Group |
| Distribution | AL, AR, CA, IL, IN, MS, OH, OK, TN |
Product
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Reason
The company has determined the sterility cannot be assured for the affected lot.
Identifiers
| code_info | M/N: 00711117; Lot #: 1505956 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0001-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.