Merit Medical Systems, Inc.: Device Recall

Recall #Z-0064-2025 · 08/19/2024

Class II: Risk

Recall Details

Recall Number
Z-0064-2025
Classification
Class II
Product Type
Device
Recalling Firm
Merit Medical Systems, Inc.
Status
Ongoing
Date Initiated
08/19/2024
Location
South Jordan, UT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,120

Reason for Recall

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Product Description

Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, 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, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

Other Recalls by Merit Medical Systems, Inc.

View all recalls by Merit Medical Systems, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.