CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report

EsophyX2 Plus Device with Serosa Fastener and Accessories recalled

Endogastric Solutions is recalling EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories, distributed nationwide in the US. The recall was initiated on 4 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 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.

Quantity recalled190

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1136-2013
FDA event ID: 64395
Recalling firm: Endogastric Solutions, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 4 Feb 2013
FDA classified: 17 Apr 2013
Reported: 24 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Feb 2013	Recall initiated by company
17 Apr 2013	Classified by FDA	+72 days
24 Apr 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Arkansas California Florida Hawaii Iowa Illinois Indiana Kentucky Louisiana Michigan North Carolina Nevada Oregon Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Is EsophyX2 Plus Device with Serosa Fastener and Accessories recalled?

Yes. Endogastric Solutions recalled EsophyX2 Plus Device with Serosa Fastener and Accessories on 4 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-1136-2013.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
28 Aug 2013Device	CLASS II	EsophyX2 Device with Serosa Fastener and Accessories recalled	Endogastric Solutions	Mold	Nationwide

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