Merit Medical Systems, Inc.: Device Recall
Recall #Z-1641-2025 · 03/14/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1641-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Merit Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 03/14/2025
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7453 units
Reason for Recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Product Description
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Distribution Pattern
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.
Other Recalls by Merit Medical Systems, Inc.
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.