# FDA recall Z-2128-2024

> **Jiangsu Shenli Medical Production Co., Ltd.** · Class II · device recall initiated 2024-04-05.

## Product

Brand Name: MEDLINE  Product Name: SYR 20ML/L PURPLE  Model/Catalog Number: 91843  Product Description: NON-Sterile syringes without needles for single use  Component: No

## Reason for recall

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

## Distribution

U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA.   After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.

## Key facts

- **Recall number:** Z-2128-2024
- **Recalling firm:** Jiangsu Shenli Medical Production Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-05
- **Report date:** 2024-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Changzhou, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2024

## Citation

> AI Analytics. FDA recall Z-2128-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2128-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*