FDA Medical devices recall ·
Merit Medical recall
- Recall number
- Z-1640-2025
- Date
- (initiated March 14, 2025)
- Company / brand
- Merit Medical Systems, Inc.
1600 W Merit Pkwy, South Jordan, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1655 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Why was it recalled?
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots/ UDI: 00810275011089
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.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1640-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.