Histolock Resection Device — Class II medical device recall Z-0001-2016
Terminated recall by US Endoscopy Group Inc, reported 2015-10-07, distributed in AL, AR, CA, IL, IN, MS, OH, OK…. The company has determined the sterility cannot be assured for the affected lot.
| Recall number | Z-0001-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Endoscopy Group Inc, Mentor, OH, United States |
| Recall initiated | 2015-07-14 |
| Classified | 2015-10-01 |
| Reported by FDA | 2015-10-07 |
| Terminated | 2016-10-27 |
| Distributed | AL, AR, CA, IL, IN, MS, OH, OK, TN |
| Quantity | 41 units |
| Reason classes | sterility |
| Lot numbers | 1505956 |
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 for recall
The company has determined the sterility cannot be assured for the affected lot.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0001-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.