# FDA recall Z-2562-2024

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2024-06-11.

## Product

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures.

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

## Distribution

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-2562-2024
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-11
- **Report date:** 2024-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2562-2024

## Citation

> AI Analytics. FDA recall Z-2562-2024. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2562-2024. Source: US FDA. Licensed CC0.

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