JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1 — Class I medical device recall Z-1798-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-06-16, distributed nationwide. Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd nu
| Recall number | Z-1798-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2021-05-17 |
| Classified | 2021-06-10 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, GB |
| Quantity | 1,432,200 units |
| Lot numbers | 4014096, 4031845, 4031846, 4040734, 4043536, 4046543, 4046545, 4046546, 4062235, 4062238, 4062239, 4062240, 4062242 |
| Model numbers | 4428-1, 4429-1 |
Product
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
Reason for recall
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
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-1798-2021. 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.