Merit Custom Syringe Kit — Class II medical device recall Z-1320-2014
Terminated recall by Merit Medical Systems, Inc., reported 2014-04-09, distributed nationwide. The products are labeled as sterile but were not sterilized.
| Recall number | Z-1320-2014 |
|---|---|
| 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 | 2014-03-13 |
| Classified | 2014-04-03 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2014-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, TH |
| Quantity | 15 |
| Reason classes | labeling, sterility |
| Lot numbers | H574228 |
Product
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Reason for recall
The products are labeled as sterile but were not sterilized.
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-1320-2014. 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.