Merit Medical Systems, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1641-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly

Product Classification:

Class II

Date Initiated: March 14, 2025

Date Posted: April 30, 2025

Recall Number: Z-1641-2025

Event ID: 96482

Reason for Recall:

Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

Status: Ongoing

Product Quantity: 7453 units

Code Information:

All Lots/ UDI: 00810275014011

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated