Z-1982-2013Class II

EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated...

Name: Z-1982-2013 EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated...
Creator: Endogastric Solutions Inc
Published: 2013-06-06
License: https://open.fda.gov/license/

Endogastric Solutions, Inc. / initiated 2013-06-06 / Terminated / root cause: manufacturing process

FDA source

Endogastric Solutions Inc began a recall of EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic... on 2013-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1982-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Posted: 2013-08-17
Terminated: 2014-04-09
Recalling firm: Endogastric Solutions, Inc.
Product: EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Product code: ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Endogastric sent the Safety Alert: EndoGastric Solutions (EGS), EsophyX2 Device letter, dated June 5, 2013, to their consignees. Endogastric sent the second letter URGENT: MEDICAL DEVICE RECALL EsophyX2, dated July 26, 2013. This letter advised customers that the firm is voluntarily recalling EsophyX2 Devices with SerosaFuse Implantable Fastener and Accessories (Models R2001 and R2002) manufactured before February 2012. Customers who have UN-EXPIRED devices in their inventory are advised to discontinue use and fill out the Medical Device Recall Return Response form and return it to Endogastric. The Customer Service will contact customers with instructions on how to return the product to the company. Customers who may have EXPIRED devices are advised to with their central supply departments to ensure all identified products have been removed from inventory and destroyed. They should fill out the Medical Device Recall Return Response form with the lot numbers and quantity destroyed and return the completed form to the firm. Customers can call the Customer Service and Support at 425-307-9269, Monday through Friday, 8:00AM to 5:00 PM, Pacific Time for questions. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 5192 units in the US and 41 units outside the US
Distribution: Distributed nationwide and Italy.
Product codes and lots: UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1982-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1982-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-17

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)