US Endoscopy Recalls Histolock Resection Device Due to Sterility Concerns
US Endoscopy Group Inc is recalling 41 units of the Histolock Resection Device because the company cannot assure the sterility of the affected lot.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device used for invasive procedures, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
US Endoscopy Group Inc is recalling 41 units of the Histolock Resection Device, an electrosurgical device used to grasp, dissect, and transect tissue during gastrointestinal endoscopic procedures. The recall was initiated because the company determined that the sterility of the affected lot cannot be assured.
The affected units are identified by Manufacturer Number 00711117 and Lot Number 1505956. These devices were distributed in the United States to the states of Alabama, Arkansas, California, Illinois, Indiana, Mississippi, Ohio, Oklahoma, and Tennessee.
Healthcare facilities and consumers should stop using the affected devices immediately and contact US Endoscopy Group Inc for further instructions on return or replacement.
The recalled product
- Product
- Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
- Manufacturer
- US Endoscopy Group Inc
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- M/N: 00711117
- Lot #: 1505956
Distribution
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