# FDA recall Z-2565-2024

> **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:    K10/K10-PI (Custom Waste Management Kit), REF:  K10T-05815  K10T-05816  K10-04722C  K10-03591KP  K10-05530  K10-04291AP  K10-04386CP  K10T-05227  K10-05120P  K10-03220AP  K10-05251AP  K10-04479P  K10-01722QP  K10-04931B  K10-04429  K10-06012P  K10-05043A  K10-06066  K10-06011AP  K10-06033AP  K10-06086P  K10-05222  K10T-00856B  K10T-01343F  K10T-03849G  K10T-05668D  K10T-05403  K10T-03958L  K10T-05139  K10-05343  K10T-04662A  K10-04800DP  K10T-05428  K10T-04278C  K10T-04942A  K10T-04216G  K10T-04110B  K10-04201GP  K10-01571C  K10T-05261  K10-04183CP  K10-00839FP  K10-00785LP  K10-00777BP  K10-04413A  K10-00592K  K10-05097A  K10-05774P  K10-05636A  K10-03327D  K10-00814L  K10-04360B  K10-03383BP  K10-01270T  K10-04621  K10-05913P  K10-05472  K10-04693D  K10-03290D  K10T-04335A  K10-04426B  K10-01700AP  K12-05018  K10-05274AP  K10-05511  K10T-04155C  K10T-03903F  K10T-04978

## 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-2565-2024
- **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-2565-2024

## Citation

> AI Analytics. FDA recall Z-2565-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2565-2024. Source: US FDA. Licensed CC0.

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