basixTOUCH Inflation Device — Class II medical device recall Z-0065-2025
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-0065-2025 |
|---|---|
| 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 | 1,952 |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00884450627105 |
| Model numbers | IN8140/A |
Product
basixTOUCH Inflation Device, REF: IN8140/A
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-0065-2025. 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.