EndoGastric Solutions Recalls EsophyX2 Plus Devices Due to Lack of Validation
EndoGastric Solutions is recalling 190 EsophyX2 Plus devices used to treat GERD because they were not validated under actual or simulated use conditions before distribution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that was not validated for use, representing a risk of harm where specific injuries have not yet been reported in the source text.
Plain-English summary
EndoGastric Solutions Inc is recalling 190 units of the EsophyX2 Plus Device with Serosa Fastener and Accessories, part number C02033-01. The device is designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis. The recall is being conducted because the device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
The affected lots are 401378, 401392, 401409, and 401416. The product was distributed nationwide, including to North Carolina, Virginia, Wisconsin, Tennessee, Kentucky, Indiana, Florida, Michigan, Iowa, Illinois, Texas, Louisiana, Arkansas, Hawaii, California, Nevada, Oregon, and Washington. Additional lots manufactured between November 26, 2012, and December 7, 2012, were placed in quarantine and were not distributed.
Physicians and healthcare facilities should stop using the recalled devices and contact EndoGastric Solutions for instructions on return or replacement. Patients who have had the device implanted should contact their physician for guidance.
The recalled product
- Product
- 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 no
- Manufacturer
- Endogastric Solutions Inc
- Affected units
- 190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots 401378
- 401392
- 401409
- 401434
- 401436
- and 401441.
Distribution
Related recalls
Same manufacturer · Endogastric Solutions Inc
See all →- SevereEndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss
FDA (Devices) · 2013-08-28
Same hazard · lack of validation
See all →- HighFDA Recalls oxyTOCIN IV Bags Over Sterility Assurance Failure
FDA (Drugs) · 2023-08-09
- HighVecuronium Injection Recalled Due to Lack of Sterility Validation
FDA (Drugs) · 2023-08-09
- ModerateLido E.R. Lidocaine Cream Recalled for Manufacturing Violations
FDA (Drugs) · 2019-07-31
- ModeratePharma-Natural Recalls Tusslin Cough Syrup Due to Manufacturing Violations
FDA (Drugs) · 2019-07-31
- ModerateFDA Recalls Oliver's Harvest CBD+Lidocaine Cream for Manufacturing Violations
FDA (Drugs) · 2019-07-31