Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Recalled by Endogastric Solutions Inc Due to EsophyX2Plus device was not validated under actual or...
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 Endogastric Solutions Inc directly.
Affected Products
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
Quantity: 190
Why Was This Recalled?
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Endogastric Solutions Inc
Endogastric Solutions Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report