Merit Medical EsophyX Z+ Fasteners Instruction Update for Over-Rotation Risk
The FDA has issued a Class II recall of Merit Medical's EsophyX Z+ with SerosaFuse Implantable Fasteners due to identified risks of device over-rotation and unintended multiple fastener deployment. The manufacturer is updating instructions for use to provide additional guidance on these risks.
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: This is a Class II recall of a surgical implant device with identified risks involving device over-rotation and fastener deployment failure that could potentially cause harm. No injuries have been reported; the recall is precautionary with an instruction update, placing it in the High severity category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling the EsophyX Z+ with SerosaFuse Implantable Fasteners (REF: R2275), a surgical fastening device. The FDA determined this Class II recall is necessary based on identified risks associated with device over-rotation and multiple deployment of fasteners.
The recall affects 7,453 units that were distributed nationwide throughout the United States and internationally to Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, and the United Arab Emirates. All lots are affected (UDI: 00810275014011).
Affected healthcare providers and facilities should review the manufacturer's updated instructions for use, which provide additional information regarding the identified risks. Consumers who have received procedures involving these devices should contact their healthcare provider for guidance.
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.
- Hazard
- over-rotation
- fastener-deployment-failure
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
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03