FDA-Device2026-01-28Class IIPROCESSING DEFECT
Merit Medical basixCOMPAK inflation device recalled for detaching handle
What this means
Merit Medical Systems' basixCOMPAK inflation device handle may detach from the syringe during a medical procedure. This affects multiple reference numbers and lots of the 20 mL, 30 atm/bar model used in clinical settings.
- If you use this device in a medical facility, stop using affected units immediately
- Check your inventory against the recalled reference numbers and lot numbers
- Contact Merit Medical Systems or your supplier for instructions on device replacement or return
- Review your procedure protocols to prevent use of recalled devices
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
4,163,123 units
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1123-2026More Merit Medical recalls
- FDA-Device2026-06-24Merit Medical Splashwire Hydrophilic Guide Wire recalled for unsealed pouches
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