Class 2 Device Recall Custom Inflation Kit

• Date Initiated by Firm: December 04, 2025
• Date Posted: January 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1126-2026
• Recall Event ID: 98139
• Product Classification: Universal drainage tray - Product Code PPD
• Product: Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
• Code Information: Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 00884450286999 T3054879 00884450286999 T3071602 00884450286999 T3105835 00884450286999 T3128753 00884450286999 T3185484 00884450286999 T3223241 00884450286999 T3229633 00884450286999 T3276968 00884450286999 T3328128 00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647 00884450140796 T2800974 00884450140796 T2823388 00884450140796 T2853488 00884450140796 T2899143 00884450140796 T2981467 00884450140796 T2987762 00884450140796 T3022097 00884450140796 T3022100 00884450140796 T3058385 00884450140796 T3083003 00884450140796 T3121582 00884450140796 T3174127 00884450140796 T3214493 00884450140796 T3229456 00884450140796 T3297510 00884450140796 T3324542 K05T-01863: 00884450315347 T2625813 00884450315347 T2718633 00884450315347 T2762715 00884450315347 T2805459 00884450315347 T2823390 00884450315347 T2863782 00884450315347 T2910718 00884450315347 T2981470 00884450315347 T2997667 00884450315347 T3036044 00884450315347 T3070773 00884450315347 T3108821 00884450315347 T3149886S 00884450315347 T3185539 00884450315347 T3214494 00884450315347 T3216705 00884450315347 T3276914 00884450315347 T3296092 00884450315347 T3328139 K05T-01915: 00884450142882 T2643556 00884450142882 T2675575 00884450142882 T2752946 00884450142882 T2842262 00884450142882 T2893876 00884450142882 T2906056 00884450142882 T2981474 00884450142882 T2987764 00884450142882 T3070812 00884450142882 T3146178 00884450142882 T3216084 00884450142882 T3269009 00884450142882 T3322767 00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916 00884450260166 T3148674 00884450260166 T3204048 00884450260166 T3322760 K05T-01955: 00884450140826 T2643557 00884450140826 T2719601 00884450140826 T2765333 00884450140826 T2823391 00884450140826 T2861459 00884450140826 T2909930 00884450140826 T2945617 00884450140826 T2985905 00884450140826 T3070951 00884450140826 T3111451 00884450140826 T3190818 00884450140826 T3214495 00884450140826 T3278749 00884450140826 T3322843 K05T-02138: 00884450140833 T2716870 00884450140833 T2726918 00884450140833 T2745251 00884450140833 T2983353 00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335 00884450095607 T3271452 00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577 00884450684023 T2726919 00884450684023 T2759596 00884450684023 T2774653 00884450684023 T2800975 00884450684023 T2810448 00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522 00884450814710 T2898650 00884450814710 T2932783 00884450814710 T2985976 00884450814710 T2987768 00884450814710 T3043834 00884450814710 T3071604 00884450814710 T3105836 00884450814710 T3126557 00884450814710 T3185542 00884450814710 T3214496 00884450814710 T3229459 00884450814710 T3276962 00884450814710 T3309860 00884450814710 T3339469 K05T-02533: 00884450255803 T2718634 00884450255803 T2809725 00884450255803 T2849216 00884450255803 T2876922 00884450255803 T2899055 00884450255803 T2909932 00884450255803 T2981490 00884450255803 T3042476 00884450255803 T3071605 00884450255803 T3123415 00884450255803 T3181209 00884450255803 T3185434 00884450255803 T3293210 00884450255803 T3315474 00884450255803 T3336070 K05T-03153: 00884450463796 T2816275 00884450463796 T2850760 00884450463796 T2939991 00884450463796 T2985985 00884450463796 T3033317 00884450463796 T3202468 K05T-03201: 00884450547915 T2656028 00884450547915 T2690357 00884450547915 T2718635 00884450547915 T2823394 00884450547915 T2983258 00884450547915 T3044905 00884450547915 T3054900 00884450547915 T3113160 00884450547915 T3190819 00884450547915 T3216029 00884450547915 T3245297 00884450547915 T3328140
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Merit Customer Service; 1800-356-3748
• Manufacturer Reason for Recall: Inflation device handle may detach from the syringe during procedure.
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 18,897 units
• 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.