ACID REFLUX RELIEF (Capsicum, Sodium Phosphate, Dibasic, Heptahydrate, Strychnos Nux-Vomica Seed, Robinia Pseudoacacia Bark, Sulfur, Sepia Officinalis Juice) Pellet [Homeocare Laboratories]
Updated Date: Mar 21, 2019 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 21, 2019 Category: Drugs & Pharmacology Source Type: alerts

Torax Medical, Inc. - LINX Reflux Management System - Class 2 Recall
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d. Product Code LXC-15; e. Product Code LXC-16; f. Product Code LXC-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2018 Category: Medical Devices Source Type: alerts

Torax Medical, Inc. - LINX Reflux Management System - Class 2 Recall
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Product Code LX-15; e. Product Code LX-16; f. Product Code LX-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2018 Category: Medical Devices Source Type: alerts

Torax Medical, Inc. - LINX Reflux Management System - Class 2 Recall
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2018 Category: Medical Devices Source Type: alerts

Torax Medical, Inc. - LINX Reflux Management System - Class 2 Recall
LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; d. Product Code LXMC-16; e. Product Code LXMC-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2018 Category: Medical Devices Source Type: alerts

Torax Medical, Inc. - LINX Reflux Management System - Class 2 Recall
LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent) in the management of their GERD. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 1, 2018 Category: Medical Devices Source Type: alerts

Mederi Therapeutics, Inc - Mederi Stretta Catheter and Accessory Kit - Class 2 Recall
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2017 Category: Medical Equipment Source Type: alerts

Covidien LLC - Bravo pH capsule delivery device - Class 2 Recall
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2016 Category: Medical Equipment Source Type: alerts

Covidien LLC - Bravo pH capsule delivery device - Class 2 Recall
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 7, 2016 Category: Medical Equipment Source Type: alerts

Endogastric Solutions Inc - EndoGastric Solutions EsophyX2 Device - Class 2 Recall
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 18, 2013 Category: Medical Equipment Source Type: alerts

Endogastric Solutions Inc - Endoscope Clip applier, Implantable Fastener and Accessories - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2013 Category: Medical Equipment Source Type: alerts