Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor Recalled by US Endoscopy Group Inc Due to US Endoscopy is conducting a voluntary product recall...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact US Endoscopy Group Inc directly.
Affected Products
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Quantity: 36 units
Why Was This Recalled?
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
Where Was This Sold?
This product was distributed to 3 states: OH, OR, WA
About US Endoscopy Group Inc
US Endoscopy Group Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report