Allwell Angioplasty Pack REF: IS-30-B1/B — Class II medical device recall Z-1129-2026
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-1129-2026 |
|---|---|
| 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 | 328,000 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884450653388 |
| Lot numbers | I2563105, I2563106, I2565007, I2598114, I2598131, I2607891, I2612499, I2618005, I2623057, I2632527, I2632528, I2639728, I2661908, I2669772, I2669774, I2827091, I2827094, I2844360, I2844361, I2897482, I2897483, I2897484, I2897485, I2924663, I2972425, I2972426, I2972427, I2972428, I2999054, I3014683, I3030198, I3048363, I3055799, I3080949, I3089230, I3099150, I3110034, I3129711, I3129712, I3161408 and 3 more |
| Model numbers | IS-30-B1/B |
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
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-1129-2026. 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.