FDA-Device2024-10-23Class II
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Merit Medical Systems, Inc.
Hazard
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.
Sold states
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.
Affected count
290
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0066-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief