Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2571-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.

Product Classification:

Class II

Date Initiated: June 11, 2024

Date Posted: August 21, 2024

Recall Number: Z-2571-2024

Event ID: 94797

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.

Status: Ongoing

Product Quantity: 900 kits

Code Information:

Catalog Number/UDI-DI code/Lot Numbers: FCL-068-00/A 00884450484326 I2902415 I2828530 FCL-069-02/A 00884450484340 I2828531 I2838807 I2851067 I2853918 I2868010 FCL-069-03/A 00884450484357 I2853921

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated