# FDA recall Z-2578-2024

> **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:    Customer Procedure Kit (Angiography/Angioplasty kit), REF:  K09T-01138  K09T-04484A  K09T-04757F  K09T-04835H  K09T-07256D  K09T-07588B  K09T-07611K  K09T-07649K  K09T-07649L  K09T-07649M  K09T-09035H  K09T-09035J  K09T-09035M  K09T-09035N  K09T-09107K  K09T-09319C  K09T-09599Q  K09T-09672H  K09T-09672J  K09T-09843AP  K09T-10192B  K09T-10405A  K09T-10449  K09T-10542G  K09T-10790D  K09T-10899C  K09T-11052F  K09T-11266B  K09T-11305F  K09T-11372G  K09T-11496A  K09T-11541B  K09T-11831C  K09T-11940A  K09T-11940B  K09T-12050D  K09T-12292B  K09T-12558D  K09T-12624B  K09T-13050F  K09T-13097B  K09T-13097C  K09T-13232  K09T-13257  K09T-13335B  K09T-13362A  K09T-13362B  K09T-13468A  K09T-13469A  K09T-13521C  K09T-13595A  K09T-13666  K09T-13801  K09T-14072A  K09T-14106  K10T-03350C  K10T-04039F  K10T-04245G  K10T-04385G  K10T-04448M  K10T-04486D  K10T-04486F  K10T-04741  K10T-04845G

## 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-2578-2024
- **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-2578-2024

## Citation

> AI Analytics. FDA recall Z-2578-2024. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2578-2024. Source: US FDA. Licensed CC0.

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