Merit Medical Systems, Inc. Recall 96482
Description: Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical Systems, Inc. Recall 96482 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1640-2025 |
| Event ID | 96482 |
| Event Description | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates. |
| Quantity | 1655 units |
| Recall Reason | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| Device Classification | 20250430 |
| Device Code Info | All Lots/ UDI: 00810275011089 |
| Center Classification Date | 20250421 |
| Recall Initiation Date | 20250314 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |