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

Reason: EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

Code information: Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.

Distribution pattern: Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,