Z-1640-2025Class II

Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Name: Z-1640-2025 Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Creator: Merit Medical Systems, Inc.
Published: 2025-03-14
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2025-03-14 / Open, Classified / root cause: labeling and UDI

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly on 2025-03-14. FDA classified it as Class II and gives the reason as "Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1640-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-14
Posted: 2025-04-21
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Product code: ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Reason for recall: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Root cause tag: labeling and UDI
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: All Lots/ UDI: 00810275011089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1640-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1640-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21
Z-1641-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-21

Product code ODE

K240879Class IIEsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. / cleared 2024-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)