1 mL Medallion¿ Syringe — Class II medical device recall Z-1889-2017
Terminated recall by Merit Medical Systems, Inc., reported 2017-05-03, distributed nationwide. Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with
| Recall number | Z-1889-2017 |
|---|---|
| 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 | 2017-03-23 |
| Classified | 2017-04-27 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-09-26 |
| Distributed | Nationwide (US) |
| Quantity | 23,032 units |
| Lot numbers | B617173, H1082598, H1082648, H1082649, H1082809, H1085511, H1085645, H1085649, H1085658, H1085659, H1085735, H1089234, H1089419, H1090184, H1092907, H1097018, H1101188, H1101443 |
| Model numbers | 701989001, K01-05197P, K01-07742P, K01-07946P, K08-02926AP, K10-05457P, MSS011, MSS011-DG, MSS011-LB, MSS011-LBP, MSS011-R, MSS011-Y, MSS011-YP, MSS011P |
Product
1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
Reason for recall
Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
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-1889-2017. 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.