Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models Recalled by Endogastric Solutions Inc Due to Endogastric Solutions, Inc. has received a limited number...
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 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Quantity: 5192 units in the US and 41 units outside the US
Why Was This Recalled?
Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.
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