PlainRecalls
FDA Devices Moderate Class II Ongoing

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Reported: January 28, 2026 Initiated: December 4, 2025 #Z-1125-2026

Product Description

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Reason for Recall

Inflation device handle may detach from the syringe during procedure.

Details

Units Affected
864 units
Distribution
Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled?
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261. Recalled by Merit Medical Systems, Inc.. Units affected: 864 units.
Why was this product recalled?
Inflation device handle may detach from the syringe during procedure.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 28, 2026. Severity: Moderate. Recall number: Z-1125-2026.