# FDA recall Z-2568-2024

> **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:    K22C (Vein Tray Angiography kit), REF:  K09T-11796F  K12T-01558G  K12T-01558H  K12T-01822  K12T-01852L  K12T-02006J  K12T-02054  K12T-02091G  K12T-02102B  K12T-02309  K12T-02392A  K12T-02416  K12T-02510N  K12T-02725G  K12T-02725H  K12T-02890K  K12T-02949A  K12T-03012C  K12T-03014B  K12T-03058A  K12T-03139  K12T-03203F  K12T-03319  K12T-03321F  K12T-03515  K12T-03560D  K12T-03566H  K12T-03638H  K12T-03706A  K12T-03746C  K12T-03788  K12T-03839H  K12T-03853C  K12T-03866B  K12T-03867A  K12T-03868  K12T-03868A  K12T-04068  K12T-04106D  K12T-04106F  K12T-04140J  K12T-04586D  K12T-04697  K12T-04959B  K12T-04963A  K12T-05061J  K12T-05081D  K12T-05093D  K12T-05281C  K12T-05334D  K12T-05423G  K12T-05442B  K12T-05472H  K12T-05559B  K12T-05824G  K12T-05824H  K12T-05825H  K12T-05926C  K12T-05991A  K12T-06033C  K12T-06211B  K12T-06250  K12T-06282  K12T-06374D  K12T-06416A  K12T-06561A

## 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-2568-2024
- **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-2568-2024

## Citation

> AI Analytics. FDA recall Z-2568-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2568-2024. Source: US FDA. Licensed CC0.

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