Merit Medical recalls EsophyX Z+ fastener delivery devices due to potential over-rotation and multiple fastener deployment risks. Affected units have specific lot numbers and require attention to prevent complications.
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Merit Medical is recalling their Esoph:Z+ fastener delivery device because updates to the user manual address risks of over-rotation and multiple fastener deployments. This could lead to complications during medical procedures if not handled correctly.
The device can over-rotate or deploy multiple fasteners during use, which may cause complications in medical procedures. This risk is related to the device's design and how it is operated by medical staff.
Medical professionals using the EsophyX Z+ device for procedures are most at risk. Patients receiving this device during surgery may also be affected.
Check for the product name 'EsophyX Z+' with lot numbers starting with 00810275011089. The device is sold only with a prescription (RxOnly).
Look for the lot number starting with 00810275011089 on the device packaging or label.
The recall is due to potential over-rotation and multiple fastener deployment risks, but the device is still considered safe with updated instructions.
Check for the lot number starting with 00810275011089 on the device packaging or label. The device is sold only with a prescription (RxOnly).
The recall does not require immediate action; check the lot number and follow the manufacturer's instructions if you have concerns.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2025 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1640-2025 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
