FDA Device recall Z-1136-2013
EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01 by Endogastric Solutions, citing esophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1136-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-04 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Endogastric Solutions |
| Distribution | US |
Product
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.
Identifiers
| code_info | Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1136-2013%22
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