Merit Medical Inflation Device — Class II medical device recall Z-1123-2026
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-1123-2026 |
|---|---|
| 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 | 4,163,123 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884450544570, 00884450544587, 00884450544594, 00884450544617, 00884450544648, 00884450636695, 00884450637524, 00884450638101, 00884450638316, 00884450638323, 00884450638347, 00884450638354, 00884450638361, 00884450638378, 00884450638385, 00884450638392, 00884450638408, 00884450638415, 00884450638422, 00884450638439, 00884450638446, 00884450638453, 00884450638460, 00884450638477, 00884450638484 and 11 more |
| Lot numbers | ENDO-AN2030/B, I2519350, I2535054, I2559550, I2559551, I2559561, I2559659, I2559662, I2559664, I2563338, I2563339, I2563340, I2563341, I2563342, I2563343, I2564655, I2564657, I2564660, I2564665, I2567481, I2567482, I2567483, I2567486, I2572851, I2572852, I2578099, I2578100, I2578105, I2578108, I2578110, I2579800, I2584021, I2584024, I2584025, I2584026, I2584111, I2584168, I2584169, I2584171, I2584172 and 460 more |
Product
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
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-1123-2026. 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.