FDAFDA · Food and drugs·Recall number Z-1640-2025
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Published April 30, 2025 · Recall initiated: March 14, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- 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.
- Lot
- All Lots/ UDI: 00810275011089
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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