# FDA recall Z-2564-2024

> **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:    K09/K09T (Custom Manifold Kit), REF:  K09-00526L  K09-00807AH  K09-01467AD  K09-01467AF  K09-01514U  K09-01734L  K09-02040C  K09-02683F  K09-02804B  K09-03844F  K09-04088H  K09-04088J  K09-04863J  K09-04946B  K09-04998H  K09-04998HP  K09-05229JP  K09-05342A  K09-05375F  K09-05939D  K09-07759J  K09-07789L  K09-07789M  K09-07828U  K09-07828UP  K09-07834C  K09-07905G  K09-08031D  K09-08052Q  K09-08065J  K09-08150R  K09-08423G  K09-08493KP  K09-08847A  K09-08875B  K09-09051H  K09-09184B  K09-09403HP  K09-09481A  K09-09499B  K09-09814  K09-09900F  K09-09902G  K09-09902GP  K09-09975  K09-10060F  K09-10062F  K09-10210A  K09-10210B  K09-10286G  K09-10300F  K09-10315B  K09-10432A  K09-10444J  K09-10475  K09-10494C  K09-10574D  K09-10726  K09-10736D  K09-10788A  K09-10811  K09-10829B  K09-10830C  K09-10929  K09-10994D  K09-11024DP  K09-11076C  K09-11107D  K09-11149B  K09-11196  K0

## 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-2564-2024
- **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-2564-2024

## Citation

> AI Analytics. FDA recall Z-2564-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2564-2024. Source: US FDA. Licensed CC0.

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