FDA DevicesClass II
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956...
Published: January 28, 2026Recall ID: Z-1128-2026Category: devicesCountry: US
Reason for Recall / Hazard
Inflation device handle may detach from the syringe during procedure.
Product Description & Identification
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Affected Products
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Additional Source Details
| Field | Value |
|---|---|
| City | South Jordan |
| State | UT |
| Event id | 98139 |
| Address 1 | 1600 W Merit Pkwy |
| Code info | Reference Number/UDI Number/Lot Number(s) K12T-04270A: UDI: 00884450389683/ Lot: T2643938 T2728112 T2783917 T2806210 T2811252 K12T-07956: UDI: 00884450264003/ Lot: K2618155 K2618156 K12T-10922B: UDI: 00884450481660/Lot: T2851185 T2876341 T2990792 T3063197 T3070788 T3165727 T3223759 T3312055 |
| Postal code | 84095-2416 |
| Report date | 20260128 |
| Product type | Devices |
| Reason for recall | Inflation device handle may detach from the syringe during procedure. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251204 |
| Initial firm notification | |
| Center classification date | 20260116 |
Overview
- Recalling FirmMerit Medical Systems, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.