FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Recall number
- Z-1640-2025
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Status
- Open, Classified
- Initiated
- 2025-03-14
- Posted
- 2025-04-21
- Terminated
- not on file
- Reason
- Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Root cause
- Under Investigation by firm
- Action
- On March 14, 2025, Merit Medical issued a "Urgent Medical Device Recall Notice via E-Mail, followed by mail to affected consignees. Merit asked consignees to take the following actions: 1. Read and understand this communication and the updated IFU referenced in the attached poster. 2. There is no need to return product to Merit. 3. Post the attached poster on or near the affected products so users are aware of the updated IFU. 4. Discard the current IFU with the product at point of use. 5. Ensure that applicable personnel within your organization are made aware of this communication. 6. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 7. If you require paper IFUs, please contact RESPONSE@merit.com. 8. Please acknowledging you are aware of the information communicated and have completed the actions required of you. 9. If you require additional product training regarding the IFU updates, please contact your Merit Sales Representative to schedule.
- Quantity
- 1655 units
- 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.
- Lot, serial or model codes
- All Lots/ UDI: 00810275011089
- 510(k) numbers
- ["K240879"]
- PMA numbers
- not on file
- Product code
- ODE
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28