ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W

There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.

On December 11, 2023, the firm notified affected consignees through URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters. Customers were instructed to cease use and distribution of affected product lots. Customers should examine their inventory immediately to determine if they have affected product. Affected product should be quarantined. Unused affected product should be returned. If you require any assistance with returning product, please contact Sedgwick at 888-591-5087 and reference Event # 6925. If you have additional questions regarding this voluntary medical device recall, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET.