Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merit Medical Recalled by Merit Medical Systems, Inc. Due to Update to IFU to provide additional information related...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merit Medical Systems, Inc. directly.
Affected Products
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Quantity: 7453 units
Why Was This Recalled?
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report