EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Endogastric Solutions Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1982-2013
Related Recalls
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.