Food, drugs, devices › Merit Medical Systems, Inc.
Device recall: Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
FDA enforcement event 95343 is a device recall by Merit Medical Systems, Inc. of South Jordan, UT, initiated 19 Aug 2024 and classified Class II, with 10 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Merit Medical Systems, Inc. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Merit Medical Systems, Inc., South Jordan, UT.
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
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0064-2025 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C | 14,120 | Class II | Ongoing | 23 Oct 2024 |
| Z-0065-2025 | basixTOUCH Inflation Device, REF: IN8140/A | 1952 | Class II | Ongoing | 23 Oct 2024 |
| Z-0066-2025 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | 290 | Class II | Ongoing | 23 Oct 2024 |
| Z-0067-2025 | IntelliSystem Inflation Device, REF: IN1525/D | 429 | Class II | Ongoing | 23 Oct 2024 |
| Z-0068-2025 | BlueFIRE Inflation Device, REF: IN10140 | 5 | Class II | Ongoing | 23 Oct 2024 |
| Z-0069-2025 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | 12,910 | Class II | Ongoing | 23 Oct 2024 |
| Z-0070-2025 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G,… | 7,099 | Class II | Ongoing | 23 Oct 2024 |
| Z-0071-2025 | basixSKY Inflation Device, REF: SKY1802 | 70 | Class II | Ongoing | 23 Oct 2024 |
| Z-0072-2025 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C | 16,439 | Class II | Ongoing | 23 Oct 2024 |
| Z-0073-2025 | StabiliT TOUCH Syringe, REF: IN8VCF/B | 202 | Class II | Ongoing | 23 Oct 2024 |
Context
Other enforcement events for Merit Medical Systems, Inc.
All 59 events for Merit Medical Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.