Merit Medical EsophyX Z+ Fastener Delivery Device Recall: Over-rotation Risk
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.
Lower-risk recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/52631-merit-medical-esophyx-z-fastener-delivery-device-recall-over-rotation.
Source Summary by GovInfoNow · govinfonow.com/recall/52631-merit-medical-esophyx-z-fastener-delivery-device-recall-over-rotation · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1640-2025
Cite this page
“Merit Medical EsophyX Z+ Fastener Delivery Device Recall: Over-rotation Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52631-merit-medical-esophyx-z-fastener-delivery-device-recall-over-rotation. Based on FDA recall #Z-1640-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Medical professionals using the EsophyX Z+ device for procedures are most at risk. Patients receiving this device during surgery may also be affected.
How to tell if you have this one
Check for the product name 'EsophyX Z+' with lot numbers starting with 00810275011089. The device is sold only with a prescription (RxOnly).
- Brand
Merit Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Brazil, Egypt, Israel, Saudi Arabia, Spain, Thailand, Turkey, United Arab Emirates.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1640-2025 | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly; All Lots/ UDI: 00810275011089 | 1655 units |
| Z-1641-2025 | Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly; All Lots/ UDI: 00810275014011 | 7453 units |
What to do — step by step
Check Device Lot Number
Look for the lot number starting with 00810275011089 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 43 states.
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this device safe to use?
The recall is due to potential over-rotation and multiple fastener deployment risks, but the device is still considered safe with updated instructions.
What should I do if I have the recalled device?
The recall does not require immediate action; check the lot number and follow the manufacturer's instructions if you have concerns.
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Where this comes from
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.
- Official source: FDA Recall #Z-1640-2025 (March 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1640-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.