Piston Syringe and Hypodermic Needle — Class II medical device recall Z-2837-201
Terminated recall by International Medsurg Connection, Inc., reported 2017-08-16, distributed nationwide. Insufficient documentation to support product sterility claims.
| Recall number | Z-2837-201 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Medsurg Connection, Inc., Schaumburg, IL, United States |
| Recall initiated | 2017-06-23 |
| Classified | 2017-08-04 |
| Reported by FDA | 2017-08-16 |
| Terminated | 2020-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 54,204,100 units |
| Reason classes | sterility |
| Model numbers | SN0032558 |
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Reason for recall
Insufficient documentation to support product sterility claims.
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-2837-201. 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.