Aspira Valve Repair Kit — Class II medical device recall Z-1916-2023
Ongoing recall by Merit Medical Systems, Inc., reported 2023-06-21, distributed nationwide. There is a potential that valve assemblies will not open. preventing fluid from draining.
| Recall number | Z-1916-2023 |
|---|---|
| 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 | 2023-04-22 |
| Classified | 2023-06-14 |
| Reported by FDA | 2023-06-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR, GB, MX |
| Quantity | 2,559 units |
| UPC / GTIN / UDI-DI | 00884450394960 |
| Lot numbers | I2558681, I2564649, I2577984, I2587036, I2604364, I2604393, I2604394, I2609065, I2623156 |
| Model numbers | 4992306 |
Product
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Reason for recall
There is a potential that valve assemblies will not open. preventing fluid from draining.
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-1916-2023. 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.