Merit Inflation Syringe Kit — Class II medical device recall Z-0002-2017
Terminated recall by Merit Medical Systems, Inc., reported 2016-10-12, distributed in CA. Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labe
| Recall number | Z-0002-2017 |
|---|---|
| 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 | 2016-08-25 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2016-12-01 |
| Distributed | CA |
| Quantity | 1,297 units |
| Reason classes | labeling |
| Lot numbers | H959038, H970334, H984351 |
| Model numbers | KOS-02857 |
Product
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Reason for recall
Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
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-0002-2017. 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.