Class 2 Device Recall Inflation Syringe

• Date Initiated by Firm: December 04, 2025
• Date Posted: January 16, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1123-2026
• Recall Event ID: 98139
• Product Classification: Syringe, Balloon Inflation, Exempt - Product Code PTM
• Product: Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
• Code Information: Reference Number/UDI Number/Lot Number(s) ENDO-AN2030/B 00884450645161 I2559664 00884450645161 I2617758 00884450645161 I2622046 00884450645161 I2657805 00884450645161 I2937082 00884450645161 I3056430 00884450645161 I3085664 00884450645161 I3118225 00884450645161 I3251180 00884450645161 I3282751 IN4130/CNK 00884450636695 I2559550 00884450636695 I2559551 00884450636695 I2563338 00884450636695 I2563339 00884450636695 I2563340 00884450636695 I2564655 00884450636695 I2564665 00884450636695 I2567481 00884450636695 I2567482 00884450636695 I2567483 00884450636695 I2578099 00884450636695 I2578100 00884450636695 I2584021 00884450636695 I2584024 00884450636695 I2584025 00884450636695 I2584026 00884450636695 I2607299 00884450636695 I2607301 00884450636695 I2607302 00884450636695 I2617759 00884450636695 I2617760 00884450636695 I2628998 00884450636695 I2629000 00884450636695 I2629001 00884450636695 I2629002 00884450636695 I2630702 00884450636695 I2648658 00884450636695 I2648659 00884450636695 I2648660 00884450636695 I2648661 00884450636695 I2657828 00884450636695 I2657833 00884450636695 I2657884 00884450636695 I2657889 00884450636695 I2663025 00884450636695 I2663026 00884450636695 I2663027 00884450636695 I2669899 00884450636695 I2669900 00884450636695 I2674531 00884450636695 I2674532 00884450636695 I2682701 00884450636695 I2682702 00884450636695 I2684463 00884450636695 I2684522 00884450636695 I2684523 00884450636695 I2699591 00884450636695 I2699592 00884450636695 I2703002 00884450636695 I2703003 00884450636695 I2703004 00884450636695 I2703006 00884450636695 I2703081 00884450636695 I2703082 00884450636695 I2703083 00884450636695 I2707735 00884450636695 I2707736 00884450636695 I2715012 00884450636695 I2715013 00884450636695 I2719928 00884450636695 I2719929 00884450636695 I2719930 00884450636695 I2719931 00884450636695 I2719933 00884450636695 I2752077 00884450636695 I2752078 00884450636695 I2755218 00884450636695 I2755219 00884450636695 I2755496 00884450636695 I2760565 00884450636695 I2773971 00884450636695 I2773972 00884450636695 I2784600 00884450636695 I2784603 00884450636695 I2844301 00884450636695 I2853612 00884450636695 I2853613 00884450636695 I2853615 00884450636695 I2858649 00884450636695 I2858650 00884450636695 I2858651 00884450636695 I2869290 00884450636695 I2886413 00884450636695 I2886423 00884450636695 I2886429 00884450636695 I2886432 00884450636695 I2887831 00884450636695 I2887832 00884450636695 I2887836 00884450636695 I2888430 00884450636695 I2892032 00884450636695 I2892033 00884450636695 I2894577 00884450636695 I2902444 00884450636695 I2902445 00884450636695 I2902446 00884450636695 I2902447 00884450636695 I2903533 00884450636695 I2903535 00884450636695 I2917165 00884450636695 I2917167 00884450636695 I2921904 00884450636695 I2921905 00884450636695 I2927911 00884450636695 I2933517 00884450636695 I2937693 00884450636695 I2937694 00884450636695 I2971987 00884450636695 I2973163 00884450636695 I2973184 00884450636695 I2976519 00884450636695 I2976520 00884450636695 I2976521 00884450636695 I2983704 00884450636695 I2986048 00884450636695 I2986049 00884450636695 I2989136 00884450636695 I2989137 00884450636695 I3001128 00884450636695 I3001129 00884450636695 I3001130 00884450636695 I3001131 00884450636695 I3013083 00884450636695 I3013085 00884450636695 I3014308 00884450636695 I3014309 00884450636695 I3014311 00884450636695 I3014312 00884450636695 I3044881 00884450636695 I3048387 00884450636695 I3056432 00884450636695 I3056433 00884450636695 I3067548 00884450636695 I3067549 00884450636695 I3072605 00884450636695 I3074753 00884450636695 I3074754 00884450636695 I3074755 00884450636695 I3074756 00884450636695 I3079091 00884450636695 I3079092 00884450636695 I3079093 00884450636695 I3079094 00884450636695 I3079095 00884450636695 I3079096 00884450636695 I3085666 00884450636695 I3085667 00884450636695 I3085668 00884450636695 I3097690 00884450636695 I3097691 00884450636695 I3098952 00884450636695 I3098953 00884450636695 I3098955 00884450636695 I3118226 00884450636695 I3118227 00884450636695 I3118228 00884450636695 I3118230 00884450636695 I3129660 00884450636695 I3129661 00884450636695 I3129662 00884450636695 I3129663 00884450636695 I3129664 00884450636695 I3146015 00884450636695 I3146016 00884450636695 I3150024 00884450636695 I3150025 00884450636695 I3150028 00884450636695 I3150029 00884450636695 I3161167 00884450636695 I3161168 00884450636695 I3161169 00884450636695 I3161170 00884450636695 I3186043 00884450636695 I3186044 00884450636695 I3186047 00884450636695 I3186048 00884450636695 I3186064 00884450636695 I3186065 00884450636695 I3204095 00884450636695 I3204096 00884450636695 I3204119 00884450636695 I3204120 00884450636695 I3204124 00884450636695 I3213949 00884450636695 I3232111 00884450636695 I3232118 00884450636695 I3232119 00884450636695 I3237621 00884450636695 I3237646 00884450636695 I3251181 00884450636695 I3251182 00884450636695 I3251183 00884450636695 I3251184 00884450636695 I3251185 00884450636695 I3251186 IN4130/H 00884450636695 I2623447 00884450636695 I2639668 00884450636695 I2657810 00884450636695 I2663024 00884450636695 I2976522 00884450636695 I2989138 00884450636695 I3014317 00884450636695 I3014321 00884450636695 I3023697 00884450636695 I3098957 00884450636695 I3118231 00884450636695 I3161171 00884450636695 I3186059 00884450636695 I3204098 00884450636695 I3213970 00884450636695 I3213991 00884450636695 I3282764 IN4130/JPH 00884450636695 I2563341 00884450636695 I2584111 00884450636695 I2593621 00884450636695 I2600945 00884450636695 I2617761 00884450636695 I2622049 00884450636695 I2648662 00884450636695 I2648663 00884450636695 I2812806 00884450636695 I2813127 00884450636695 I2819767 00884450636695 I2868572 00884450636695 I2887840 00884450636695 I2892034 00884450636695 I2917168 00884450636695 I2921906 00884450636695 I2927912 00884450636695 I2976523 00884450636695 I3001132 00884450636695 I3014322 00884450636695 I3023700 00884450636695 I3037358 00884450636695 I3074757 00884450636695 I3085670 00884450636695 I3098958 00884450636695 I3110563 00884450636695 I3146019 00884450636695 I3200761 00884450636695 I3213973 00884450636695 I3232041 00884450636695 I3262820 00884450636695 I3282766 IN4130/K 00884450637524 I2719948 00884450637524 I2559561 00884450637524 I2572851 00884450637524 I2572852 00884450637524 I2617762 00884450637524 I2649063 00884450637524 I2649065 00884450637524 I2707737 00884450637524 I2714726 00884450637524 I2719962 00884450637524 I2748232 00884450637524 I2748233 00884450637524 I2748234 00884450637524 I2755246 00884450637524 I2759867 00884450637524 I2759868 00884450637524 I2759871 00884450637524 I2760566 00884450637524 I2770156 00884450637524 I2773967 00884450637524 I2773969 00884450637524 I2773970 00884450637524 I2784607 00884450637524 I2784608 00884450637524 I2853617 00884450637524 I2854185 00884450637524 I2858648 00884450637524 I2868573 00884450637524 I2868574 00884450637524 I2887838 00884450637524 I2887839 00884450637524 I2892035 00884450637524 I2903541 00884450637524 I2903542 00884450637524 I2917171 00884450637524 I2917172 00884450637524 I2918172S1 00884450637524 I2921907 00884450637524 I2921908 00884450637524 I2927913 00884450637524 I2933518 00884450637524 I2937696 00884450637524 I2937697 00884450637524 I2976524 00884450637524 I2988260S1 00884450637524 I2989139 00884450637524 I2989140 00884450637524 I2989141 00884450637524 I3001133 00884450637524 I3014325 00884450637524 I3014326 00884450637524 I3014327 00884450637524 I3014328 00884450637524 I3031136 00884450637524 I3031137 00884450637524 I3047976 00884450637524 I3048199 00884450637524 I3059081 00884450637524 I3074758 00884450637524 I3074759 00884450637524 I3084132 00884450637524 I3085671 00884450637524 I3097692 00884450637524 I3098960 00884450637524 I3118232 00884450637524 I3129665 00884450637524 I3129666 00884450637524 I3129667 00884450637524 I3150026 00884450637524 I3161172 00884450637524 I3161173 00884450637524 I3161174 00884450637524 I3182211 00884450637524 I3199105 00884450637524 I3199127 00884450637524 I3199131 00884450637524 I3204113 00884450637524 I3204114 00884450637524 I3204117 00884450637524 I3204121 00884450637524 I3204122 00884450637524 I3204123 00884450637524 I3232112 00884450637524 I3248089 00884450637524 I3262821 00884450637524 I3290570 00884450637524 I3290571 00884450637524 I3310655 00884450637524 I3310659 00884450637524 I3359468 IN4130/KRK 00884450751121 I2917719 00884450751121 I2933519 00884450751121 I2976526 00884450751121 I3014329 00884450751121 I3056436 00884450751121 I3074760 00884450751121 I3119323 00884450751121 I3232075 IN4130/L 00884450638101 I2593642 00884450638101 I2593643 00884450638101 I2593648 00884450638101 I2593649 00884450638101 I2628991 00884450638101 I2628993 00884450638101 I2639673 00884450638101 I2648667 00884450638101 I2657830 00884450638101 I2657831 00884450638101 I2669897 00884450638101 I2693439 00884450638101 I2693440 00884450638101 I2693441 00884450638101 I2703009 00884450638101 I2714727 00884450638101 I2755249 00884450638101 I2759872 00884450638101 I2759873 00884450638101 I2784624 00884450638101 I2812807 00884450638101 I2834503 00884450638101 I2839309 00884450638101 I2844308 00884450638101 I2853620 00884450638101 I2858643 00884450638101 I2868575 00884450638101 I2887843 00884450638101 I2887844 00884450638101 I2903545 00884450638101 I2921909 00884450638101 I2921910 00884450638101 I2927914 00884450638101 I2933520 00884450638101 I2933521 00884450638101 I2976527 00884450638101 I2989152 00884450638101 I2989153 00884450638101 I3001134 00884450638101 I3001135 00884450638101 I3014332 00884450638101 I3014333 00884450638101 I3014334 00884450638101 I3023701 00884450638101 I3023702 00884450638101 I3031138 00884450638101 I3048389 00884450638101 I3056437 00884450638101 I3056438 00884450638101 I3074761 00884450638101 I3074762 00884450638101 I3079097 00884450638101 I3079098 00884450638101 I3085672 00884450638101 I3098961 00884450638101 I3098962 00884450638101 I3098963 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• 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: 4,163,123 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.