Merit Medical Systems, Inc. is recalling approximately 9,108 EsophyX Z+ Fastener Delivery Devices to update the Instructions for Use (IFU). The update adds critical safety information regarding risks associated with over-rotating the device or deploying multiple fasteners during a procedure. This recall affects models R2007 and R2275, which were distributed to hospitals and surgical centers worldwide. No injuries or incidents have been reported at this time.
Improper use of the device, specifically over-rotation or incorrect multiple deployment of fasteners, may lead to procedural complications or injury to the patient during surgery.
Recall #: Z-1640-2025; Quantity: 1655 units
Recall #: Z-1641-2025; Quantity: 7453 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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