EndoGastric Solutions EsophyX2 Device with Serosa Fastener and… — Class II medical device recall Z-1982-2013
Terminated recall by Endogastric Solutions Inc, reported 2013-08-28, distributed nationwide. Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold contr
| Recall number | Z-1982-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endogastric Solutions Inc, Redmond, WA, United States |
| Recall initiated | 2013-06-06 |
| Classified | 2013-08-17 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Reason classes | microbial contamination |
| Pathogens | mold |
| 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 and 37 more |
| Model numbers | R2001, R2002 |
| Expiration dates | 2013-08-31 |
Product
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
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.
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-1982-2013. 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.