Jelco — Class II medical device recall Z-2670-2017
Terminated recall by Smiths Medical ASD Inc., reported 2017-07-12. Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation
| Recall number | Z-2670-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2017-04-04 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2019-08-05 |
| Quantity | 736,000 |
| Model numbers | 1915, 3297458, 3297459, 3297465, 3297466, 3297467, 5021, 600/CA, EL1915, SB5021 |
Product
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Reason for recall
Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.
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-2670-2017. 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.