Disposable Insulin Syringe 0 — Class II medical device recall Z-3202-2018
Terminated recall by ShinChang Medical Co., Ltd., reported 2018-09-26, distributed in FL, TN, VA. Defect consists of a small crack in the top end of the barrel near the needle.
| Recall number | Z-3202-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ShinChang Medical Co., Ltd., Gumi, N/A, Korea (the Republic of) |
| Recall initiated | 2018-08-24 |
| Classified | 2018-09-20 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2023-01-04 |
| Distributed | FL, TN, VA |
| Quantity | 6,570,800 |
| Reason classes | packaging |
Product
Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
Reason for recall
Defect consists of a small crack in the top end of the barrel near the needle.
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-3202-2018. 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.