Recall Z-1128-2026
Merit Medical Systems, Inc. · initiated December 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Codes / lots: 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
Reason for recall
Inflation device handle may detach from the syringe during procedure.
FDA-determined cause: Process control
Action taken
On December 4, 2025 Merit Medical issued a "Urgent Medical Device Recall Notice" to affected consignees via E-Mail. Merit asked consignees to take the following actions: 1. Please read and understand the recall notification. 2. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast 3. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. Please fill out, scan, and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within seven (7) calendar days
Details
- Recall number
- Z-1128-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 16, 2026
- Product code
- OEQ – Angiography/Angioplasty Kit
- Distribution
- 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…
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1123-2026 Class II | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers:…Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1124-2026 Class II | Allwell Inflation Device, for angiographic use REF: IS-30-AInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1125-2026 Class II | Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1126-2026 Class II | Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C…Inflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1127-2026 Class II | Merit Medical , Custom Manifold Kit REF: K09-13203AInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |
| Z-1129-2026 Class II | Allwell Angioplasty Pack REF: IS-30-B1/BInflation device handle may detach from the syringe during procedure. | 12/04/2025Open, Classified |