CLASS II Device recall · Reported 7 Oct 2015 · FDA Enforcement Report
Histolock Resection Device, US Endoscopy recalled by US Endoscopy Group
US Endoscopy Group is recalling Histolock Resection Device, US Endoscopy, distributed in 9 states. The recall was initiated on 14 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0001-2016
- FDA event ID
- 71987
- Recalling firm
- US Endoscopy Group, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jul 2015
- FDA classified
- 1 Oct 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 14 Jul 2015 | Recall initiated by company | |
| 1 Oct 2015 | Classified by FDA | +79 days |
| 7 Oct 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The company has determined the sterility cannot be assured for the affected lot.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Where it was distributed
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
AlabamaArkansasCaliforniaIllinoisIndianaMississippiOhioOklahomaTennessee
Questions about this recall
Is Histolock Resection Device, US Endoscopy recalled?
Yes. US Endoscopy Group recalled Histolock Resection Device, US Endoscopy on 14 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-0001-2016.
Why was it recalled?
The company has determined the sterility cannot be assured for the affected lot.
Which lots are affected?
M/N: 00711117; Lot #: 1505956
Where was it sold?
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from US Endoscopy Group
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |