# FDA recall Z-1798-2021

> **Smiths Medical ASD Inc.** · Class I · device recall initiated 2021-05-17.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of UK,  Spain.

## Key facts

- **Recall number:** Z-1798-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-17
- **Report date:** 2021-06-16
- **Termination date:** 2023-10-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2021

## Citation

> AI Analytics. FDA recall Z-1798-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1798-2021. Source: US FDA. Licensed CC0.

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