Merit Medical — Class II medical device recall Z-1126-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2026-01-28, distributed nationwide. Inflation device handle may detach from the syringe during procedure.
| Recall number | Z-1126-2026 |
|---|---|
| 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 | 2025-12-04 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, ID, IE, IL, IN, IS, IT, JM, JP, KR, KW, KY, LB, LK, LU, LV, MX, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PK, PL, PT, PY, QA, RO, RS, SA, SE, SI, SK, SV, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 18,897 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884450095607, 00884450139325, 00884450139950, 00884450140406, 00884450140796, 00884450140826, 00884450140833, 00884450141663, 00884450141687, 00884450141878, 00884450142882, 00884450255803, 00884450260166, 00884450286999, 00884450294918, 00884450298350, 00884450315347, 00884450463796, 00884450547915, 00884450684023, 00884450756102, 00884450814710 |
| Lot numbers | H2613573, H2650871, H2697189, H2725969, H2736533, H2767978, H2787955, H2801768, H2823896, H2844892, H2849102, H2854783, H2864807, H2867356, H2869821, H2872045, H2911094, H2920493, H2937574, H2980776, H2994406, H3006229, H3030118, H3041746, H3068295, H3077898, H3079962, H3096168, H3115553, H3125118, H3136596, H3147935, H3179116, H3183526, H3183534, H3191157, H3215391, H3227692, H3248072, H3266089 and 179 more |
| Model numbers | K05-00761F, K05-01717B, K05-02080D, K05-02090C, K05-02221, K05-02338, K05-02470, K05-02954, K05-03094A, K05T-00380C, K05T-01674B, K05T-01863, K05T-01915, K05T-01920F, K05T-01955, K05T-02138, K05T-02138A, K05T-02272G, K05T-02272H, K05T-02533, K05T-03153, K05T-03201 |
Product
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
Reason for recall
Inflation device handle may detach from the syringe during procedure.
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-1126-2026. 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.