FDAFDA · Food and drugs·Recall number Z-0066-2025
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Published October 23, 2024 · Recall initiated: August 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Merit Medical Systems, Inc.
- Distributor
- 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.
- Lot
- REF/UDI-DI/Lot(Expiration): IN9135/A/00884450409640/H2918441(4/15/2027). IN9152/A/00884450409657/H2912682(4/8/2027)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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