Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

FDA device recall Z-1128-2026 · posted 2026-01-16 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Inflation device handle may detach from the syringe during procedure.

Action taken

On December 4, 2025 Merit Medical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. Merit asked consignees to take the following actions: 1. Please read and understand the recall notification. 2. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast 3. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. Please fill out, scan, and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within seven (7) calendar days

Root cause

Process control

Status

Open, Classified

Product code

OEQ

Distribution

Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, N

Date initiated

2025-12-04

Date posted

2026-01-16

Location

South Jordan, UT