Recall Z-1641-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-1641-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-14

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-03-14. It names one FDA 510(k) clearance: K240879. Product: Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly. Reason: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-03-14
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.·cleared 2024-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.