EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and… — Class II medical device recall Z-1136-2013
Terminated recall by Endogastric Solutions Inc, reported 2013-04-24, distributed nationwide. EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the produ
| Recall number | Z-1136-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endogastric Solutions Inc, Redmond, WA, United States |
| Recall initiated | 2013-02-04 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-07-02 |
| Distributed | Nationwide (US) |
| Quantity | 190 |
| Lot numbers | 401378, 401392, 401409, 401416 |
| Model numbers | 2-LINK, C02033-01 |
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 for recall
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1136-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.