# FDA recall Z-2567-2024

> **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:    K12T/12PI (Custom Pressure Monitoring Kit), REF:  K12-03846  K12-04185A  K12-03447  K12M-02489  K12-10056  K12-02489A  K12-02097B  K12-12335  K12-12192P  K12-12079P  K12-04262BP  K12-11132B  K12-12382  K12-09098C  K12-02112  K12-02111  K12-05576G  K12-05805A  K12T-10313C  K12-11821P  K12-01348D  K12-11821  K12-11426  K12-06318  K12-12053  K12-03438  K12-07208A  K12-12147  K12-09009  K12-10375  K12-08716  K12-11669AP  K12-00657A  K12-11131AP  K12-10914  K12-07299P  K12-05494  K12-00443A  K12-08303  K12-06509A  K12-10962  K12-11133  K12-06509B    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-2567-2024
- **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-2567-2024

## Citation

> AI Analytics. FDA recall Z-2567-2024. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2567-2024. Source: US FDA. Licensed CC0.

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