basixALPHA Inflation Device 30 atm/bar 20 mL — Class II medical device recall Z-2166-2021
Terminated recall by Merit Medical Systems, Inc., reported 2021-08-04, distributed nationwide. Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
| Recall number | Z-2166-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2021-06-10 |
| Classified | 2021-07-29 |
| Reported by FDA | 2021-08-04 |
| Terminated | 2024-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CH, CN, DE, DK, ES, FI, FR, GB, IL, JP, KE, NL, NO, NZ, QA, SA, SE, SK, ZA |
| Quantity | 7,211 devices |
| UPC / GTIN / UDI-DI | 00884450440179, 00884450510155, 00884450511220, 00884450511305, 00884450511510 |
| Lot numbers | H1862928, H1896261, H1896262, H1896263, H18962650, H1909581, H1923761, H1923762, H1929106, H1929107, H1939255, H1939259, H1966485, H1966489, H1966490, H1973390, H1978295, H1978299, H1978305, H1993118, H2001426, H2007415, H2007417, H2012534, H2031599, H2031601, H2068264, H2068265, H2073193, H2073198, H2073247, H2073248, H2073249, H2077173, H2077175, H2077176, H2084368 |
| Model numbers | IN3130, IN3152, IN3302, IN3802 |
Product
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Reason for recall
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
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-2166-2021. 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.