Merit Medical EsophyX Z+ Fastener Delivery Device Instructions Update
Merit Medical has updated instructions for the EsophyX Z+ fastener delivery device to provide additional information about risks associated with device over-rotation and multiple fastener deployment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an instructional update for a medical device. The source text does not report any illnesses, injuries, or deaths, and the hazard is addressed through updated labeling and instructions rather than a physical device defect. Per the rubric, this constitutes a moderate severity recall.
Plain-English summary
Merit Medical Systems, Inc. has issued an update to the instructions for use (IFU) for the EsophyX Z+ with SerosaFuse Implantable Fasteners system. The update provides additional information related to risks with device over-rotation and multiple deployment of fasteners.
The affected product is the Merit Medical REF: R2275 EsophyX Z+ system, which includes a fastener delivery device and 7.5mm cartridges. Approximately 7,453 units have been distributed worldwide, including throughout the United States and to Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, and the United Arab Emirates.
Healthcare providers and facilities using this device should review the updated instructions for use to understand the risks associated with over-rotation and multiple fastener deployment.
The recalled product
- Product
- Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 7,453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI: 00810275014011
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Same hazard · device over rotation
See all →- ModerateMerit Medical EsophyX Z+ Fastener Delivery Device Safety Update
FDA (Devices) · 2025-04-30
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