Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety… — Class II medical device recall Z-1733-2019
Terminated recall by Smiths Medical ASD Inc., reported 2019-06-12, distributed nationwide. Incorrect needle length and gage.
| Recall number | Z-1733-2019 |
|---|---|
| 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 | 2019-02-11 |
| Classified | 2019-06-04 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-06-23 |
| Distributed | Nationwide (US) |
| Lot numbers | 3707576 |
| Model numbers | 402010 |
Product
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
Reason for recall
Incorrect needle length and gage.
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-1733-2019. 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.