FDA DevicesClass II
Merit Medical , Custom Manifold Kit REF: K09-13203A
Published: January 28, 2026Recall ID: Z-1127-2026Category: devicesCountry: US
Reason for Recall / Hazard
Inflation device handle may detach from the syringe during procedure.
Product Description & Identification
Merit Medical , Custom Manifold Kit REF: K09-13203A
Affected Products
Merit Medical , Custom Manifold Kit REF: K09-13203A
Additional Source Details
| Field | Value |
|---|---|
| City | South Jordan |
| State | UT |
| Event id | 98139 |
| Address 1 | 1600 W Merit Pkwy |
| Code info | K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407 |
| Postal code | 84095-2416 |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 2192 units |
| 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.