Reported Aug 28, 2013 · Terminated
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the…
Endogastric Solutions Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endogastric Solutions Inc · 8210 154th Ave NE · Redmond, WA · 98052-3877
Is this the product you have?
- EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
- Lot codes and dates
- UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014)
- and following LOT numbers401132, 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
400923400927400934400937400940400943400949400961400963400973400976400979400980400981400984400986400992400994400997400998401004401005401009401012401016401017401024401026401029401056401058401059401060401061401062401063401065401072401074401076401079401084401085401092401094401107401114401115401121401129and 401130
- Amount recalled
- 5192 units in the US and 41 units outside the US
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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