# FDA recall Z-1733-2019

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2019-02-11.

## 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.

## Distribution

US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.

## Key facts

- **Recall number:** Z-1733-2019
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-11
- **Report date:** 2019-06-12
- **Termination date:** 2020-06-23

- **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-1733-2019

## Citation

> AI Analytics. FDA recall Z-1733-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1733-2019. Source: US FDA. Licensed CC0.

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