Z-0064-2025 Class II Ongoing
FDA device recall Z-0064-2025 was initiated by Merit Medical Systems, Inc. on Aug 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 14,120.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 23, 2024
- Initiation Date
- Aug 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,120
Product Description
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
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.
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.
Code Information
REF/UDI-DI/Lot(Expiration): IN7152/C/00884450381168/H2918432(4/15/2027), H2925197(4/22/2027), H2929406(4/29/2027), H2929407(4/29/2027, H2934708(5/5/2027), H2937991(6/3/2027), H2937992(5/19/2027), H2943482(5/19/2027), H2972588(6/3/2027), H2972589(5/26/2027).: . IN7352/C/00884450409879/H2934710(5/5/2027). IN7403/C/00884450409886/H2943483(4/30/2027). IN7802/C/00884450498743/H2918435(4/22/2027), H2929409(4/29/2027), H2934711(5/5/2027), H2937995(5/12/2027), H2943485(5/19/2027), H2978087(6/3/2027). IN7852/C/00884450498750/H2937355(9/30/2025). IN7130/C/00884450409855/H2918431(4/15/2027), H2925196(4/22/2027), H2934706(5/5/2027), H2937988(6/3/2027), H2943481(5/19/2027), H2972587(5/26/2027), H2978086(6/3/2027).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0064-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026