FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical Custom Manifold Kit recalled for detachable inflation device handle
OTHERNationwide distribution
Stop using Merit Medical Custom Manifold Kit
Merit Medical Systems is recalling its Custom Manifold Kit (model K09-13203A) because the inflation device handle may detach from the syringe during a medical procedure. This could interrupt treatment or require procedure restart. No injuries have been reported.
- Stop using any Custom Manifold Kit with lot numbers H2671718 through H3254530 (check your packaging)
- Contact Merit Medical Systems or your healthcare provider for a replacement
- Report any problems with the device to the FDA's MedWatch program at 1-888-SAFEMED or online
Hazard
Inflation device handle may detach from the syringe during procedure.
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
2192 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Merit Medical , Custom Manifold Kit REF: K09-13203A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2026More Merit Medical Systems, Inc. recalls
- FDA-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
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