[pending] Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Pending LLM rewrite. Source: FDA_DEVICE Z-1640-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
The recalled product
- Product
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Devices
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: 00810275011089
Distribution
Distributed nationwide across the United States.
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