Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse… recallZ-1641-2025 · Merit Medical Systems, Inc. · initiated Mar 14, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-1641-2025
Status: Open, Classified
Initiated by the company: Mar 14, 2025
Posted by the FDA: Apr 21, 2025
Recalling firm: Merit Medical Systems, Inc.
Quantity: 7453 units
Product code: ODE
FDA submissions: K240879
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 description

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

Code information (models, lots, serial numbers)

All Lots/ UDI: 00810275014011

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

SerosaFuse® Implantable Fastener Kit R2275
Endogastric Solutions, Inc. · Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
1 recall22 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 96482).

Z-1640-2025 · Open, Classified
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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