Z-1136-2013Class II

EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label...

Name: Z-1136-2013 EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label...
Creator: Endogastric Solutions Inc
Published: 2013-02-04
License: https://open.fda.gov/license/

Endogastric Solutions, Inc. / initiated 2013-02-04 / Terminated

FDA source

Endogastric Solutions Inc began a recall of EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1)... on 2013-02-04. FDA classified it as Class II and gives the reason as "EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1136-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Posted: 2013-04-17
Terminated: 2013-07-02
Recalling firm: Endogastric Solutions, Inc.
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
Product code: ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Reason for recall: EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
FDA root cause: Release of Material/Component prior to receiving test results
Action: EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.
Quantity in commerce: 190
Distribution: Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1136-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1136-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code ODE

K092400Class IIEndogastric Solutions Esophyx2 System with Serosafuse Fastener and Accessories, Model 2.7.5Endogastric Solutions, Inc. / cleared 2009-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)