FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical Custom Procedure Kit recalled for detaching inflation device handle
What this means
Merit Medical Systems is recalling certain Custom Procedure Kits because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt the procedure or cause other complications. No injuries have been reported.
- Check if you have one of the affected kits by matching the reference numbers (K12T-04270A, K12T-07956, or K12T-10922B) and lot numbers listed in this recall.
- Stop using affected kits immediately and do not use them on patients.
- Contact Merit Medical Systems or your distributor for instructions on returning or replacing the kits.
- Check with your healthcare facility's safety officer or the FDA if you have questions about which kits you have.
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.
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2026Want us to check the next one for you?
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