Z-1641-2025 Class II Ongoing
FDA device recall Z-1641-2025 was initiated by Merit Medical Systems, Inc. on March 14, 2025 and is designated Class II. Reason for recall: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. The recall status is ongoing. Affected quantity: 7453 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- March 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7453 units
Product Description
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reason for Recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
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.
Code Information
All Lots/ UDI: 00810275014011