FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical Custom Waste Management Kit Vascular Tray recalled for detaching inflation device handle
What this means
Merit Medical Systems is recalling specific lots of their Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt patient care. No injuries have been reported.
- If you use this product, stop using affected lot numbers immediately: T2736369, T2781930, T2898771S, T3047503, T3090431, T3121937, T3146114, T3158708, T3204129, T3232415
- Contact Merit Medical Systems or your supplier for instructions on returning or replacing the product
- Review your records to identify affected units in your facility
The agency's original wording
Hazard
Inflation device handle may detach from the syringe during procedure.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
864 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1125-2026More Merit Medical recalls
- FDA-Device2026-06-24Merit Medical Splashwire Hydrophilic Guide Wire recalled for unsealed pouches
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