Merit Medical Systems, Inc.: Device Recall
Recall #Z-1129-2026 · 12/04/2025
Recall Details
- Recall Number
- Z-1129-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Merit Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 12/04/2025
- Location
- South Jordan, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 328000 units
Reason for Recall
Inflation device handle may detach from the syringe during procedure.
Product Description
Allwell Angioplasty Pack REF: IS-30-B1/B
Distribution Pattern
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.
Other Recalls by Merit Medical Systems, Inc.
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025
- Class II: Risk 12/04/2025