Custom Inflation Kit — Class II medical device recall Z-0070-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2024-10-23, distributed nationwide. Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may r
| Recall number | Z-0070-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-08-19 |
| Classified | 2024-10-11 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR, IE, IN, IT, JM, JP, NP, PY |
| Quantity | 7,099 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00884450046951, 00884450047057, 00884450052921, 00884450052952, 00884450138120, 00884450138298, 00884450138304, 00884450138427, 00884450138519, 00884450138588, 00884450139738, 00884450140468, 00884450141458, 00884450142295, 00884450142301, 00884450142448, 00884450145401, 00884450145449, 00884450146538, 00884450147931, 00884450148372, 00884450148884, 00884450150191, 00884450151631, 00884450152324 and 25 more |
| Model numbers | 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, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G and 26 more |
Product
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, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0070-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.