FDA recall, , Moderate risk
Merit Medical Inflation Devices and Custom Kits
Inflation device handle may detach from the syringe during procedure.
Summary by Recall Canary from the FDA notice
What happened
Merit Medical Systems, Inc., of South Jordan, Utah, recalled multiple inflation devices and kits because the inflation device handle may detach from the syringe during procedure. The recall began December 4, 2025, and was classified by the FDA on January 16, 2026. The products were distributed nationwide and worldwide, including in the United States, Puerto Rico, and many other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Merit Medical , Custom Inflation Kit
Product details from the notice
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
- UDI-DI
- 00884450294918
- 00884450139325
- 00884450141663
- 00884450141687
- 00884450141878
- 00884450139950
- 00884450140406
- 00884450298350
- 00884450756102
- 00884450286999
- 00884450140796
- 00884450315347
- 00884450142882
- 00884450260166
- 00884450140826
- 00884450140833
- 00884450095607
- 00884450684023
- 00884450814710
- 00884450255803
- 00884450463796
- 00884450547915
- Lot code
- K05-00761F
- H2801768
- H2872045
- K05-01717B
- H2613573
- H2650871
- H2697189
- H2736533
- H2767978
- H2787955
- H2823896
- H2844892
- H2849102
- H2854783
- H2864807
- H2869821
- H2911094
- H2920493
- H2937574
- H2980776
- H3006229
- H3030118
- H3041746
- H3068295
- H3077898
- H3096168
- H3115553
- H3125118
- H3136596
- H3147935
- H3179116
- H3191157
- H3215391
- H3227692
- H3266089
- H3324827
- K05-02080D
- H3248072
- K05-02090C
- H3079962
- K05-02221
- H2867356
- H3183526
- K05-02338
- H2994406
- K05-02470
- H3183534
- K05-02954
- H2725969
- K05-03094A
- I2725535
- I3254468
- K05T-00380C
- T2636525
- T2697344
- T2730359
- T2745227
- T2779731
- T2792255
- T2805457
- T2842259
- T2865498
- T2916415
- T2981465
- T2985902
- T3039943
- T3054879
- T3071602
- T3105835
- T3128753
- T3185484
- T3223241
- T3229633
- T3276968
- T3328128
- T3356293
- K05T-01674B
- T2774647
- T2800974
- T2823388
- T2853488
- T2899143
- T2981467
- T2987762
- T3022097
- T3022100
- T3058385
- T3083003
- T3121582
- T3174127
- T3214493
- T3229456
- T3297510
- T3324542
- K05T-01863
- T2625813
- T2718633
- T2762715
- T2805459
- T2823390
- T2863782
- T2910718
- T2981470
- T2997667
- T3036044
- T3070773
- T3108821
- T3149886S
- T3185539
- T3214494
- T3216705
- T3276914
- T3296092
- T3328139
- K05T-01915
- T2643556
- T2675575
- T2752946
- T2842262
- T2893876
- T2906056
- T2981474
- T2987764
- T3070812
- T3146178
- T3216084
- T3269009
- T3322767
- T3356295
- K05T-01920F
- T3093916
- T3148674
- T3204048
- T3322760
- K05T-01955
- T2643557
- T2719601
- T2765333
- T2823391
- T2861459
- T2909930
- T2945617
- T2985905
- T3070951
- T3111451
- T3190818
- T3214495
- T3278749
- T3322843
- K05T-02138
- T2716870
- T2726918
- T2745251
- T2983353
- T3216028
- K05T-02138A
- T3232335
- T3271452
- T3306685
- K05T-02272G
- T2675577
- T2726919
- T2759596
- T2774653
- T2800975
- T2810448
- T2843256
- K05T-02272H
- T2871522
- T2898650
- T2932783
- T2985976
- T2987768
- T3043834
- T3071604
- T3105836
- T3126557
- T3185542
- T3214496
- T3229459
- T3276962
- T3309860
- T3339469
- K05T-02533
- T2718634
- T2809725
- T2849216
- T2876922
- T2899055
- T2909932
- T2981490
- T3042476
- T3071605
- T3123415
- T3181209
- T3185434
- T3293210
- T3315474
- T3336070
- K05T-03153
- T2816275
- T2850760
- T2939991
- T2985985
- T3033317
- T3202468
- K05T-03201
- T2656028
- T2690357
- T2718635
- T2823394
- T2983258
- T3044905
- T3054900
- T3113160
- T3190819
- T3216029
- T3245297
- T3328140
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
- UDI-DI
- 00884450320297
- Lot code
- T2736369
- T2781930
- T2898771S
- T3047503
- T3090431
- T3121937
- T3146114
- T3158708
- T3204129
- T3232415
Merit Medical , Custom Procedure Kit
- UDI-DI
- 00884450389683
- 00884450264003
- 00884450481660
- Reference code
- K12T-04270A
- K12T-07956
- K12T-10922B
- Lot code
- K12T-04270A
- T2643938
- T2728112
- T2783917
- T2806210
- T2811252
- K12T-07956
- K12T-10922B
- T2851185
- T2876341
- T2990792
- T3063197
- T3070788
- T3165727
- T3223759
- T3312055
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL
- UDI-DI
- 00884450645161
- 00884450636695
- 00884450637524
- 00884450751121
- 00884450638101
- 00884450860953
- 00884450658963
- 00884450638316
- 00884450675120
- 00884450638323
- 00884450638347
- 00884450638354
- 00884450638361
- 00884450638378
- 00884450860106
- 00884450638385
- 00884450860113
- 00884450638392
- 00884450638408
- 00884450638415
- 00884450638422
- 00884450638439
- 00884450638446
- 00884450638453
- 00884450638460
- 00884450544570
- 00884450544587
- 00884450544594
- 00884450638477
- 00884450544617
- 00884450638484
- 00884450638491
- 00884450544648
- 00884450638514
- 00884450638521
- 00884450638538
- Reference code
- 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
- Lot code
- ENDO-AN2030
- I2559664
- I2617758
- I2622046
- I2657805
- I2937082
- I3056430
- I3085664
- I3118225
- I3251180
- I3282751
- IN4130
- I2559550
- I2559551
- I2563338
- I2563339
- I2563340
- I2564655
- I2564665
- I2567481
- I2567482
- I2567483
- I2578099
- I2578100
- I2584021
- I2584024
- I2584025
- I2584026
- I2607299
- I2607301
- I2607302
- I2617759
- I2617760
- I2628998
- I2629000
- I2629001
- I2629002
- I2630702
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- I2669900
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- I2699591
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- I2886413
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- I2902444
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- I2933517
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- I2976519
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- I2976521
- I2983704
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- I2986049
- I2989136
- I2989137
- I3001128
- I3001129
- I3001130
- I3001131
- I3013083
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- I3014308
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- I3014311
- I3014312
- I3044881
- I3048387
- I3056432
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- I3129664
- I3146015
- I3146016
- I3150024
- I3150025
- I3150028
- I3150029
- I3161167
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- IN4352
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- I3146027
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- I3213947
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- I2563342
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- I2579800
- I2584172
- I2593670
- I2593671
- I2607461
- I2617778
- I2618399S1
- I2622055
- I2648681
- I2648682
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- I2663018
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- I3232088
- I3245228
- I3248056
- I3250060
- I3282780
- I3290580
- I3310666
- IN4802
- I2563343
- I2593673
- I2593675
- I2596323
- I2596324
- I2596325
- I2617779
- I2629004
- I2657832
- I2669888
- I2678044
- I2684460
- I2689143
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- I3138883
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- I3172451
- I3234856
- I3251194
- I3275873
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- I3290585
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- I3310668
- I3333086
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- IN4901
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- I2747555
- I2822684
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- I2887841
- I2887842
- I2917181
- I2921919
- I2976563
- I2989168
- I3014360
- I3037365
- I3048395
- I3056443
- I3079104
- I3097698
- I3098974
- I3118241
- I3141085
- I3146032
- I3186061
- I3200766
- I3206777
- I3213971
- I3232096
- I3242604
- I3251195
- I3279228
- I3290595
- I3298681
- I3333091
- IN4902
- I2607468
- I2684465
- I2738937
- I2844331
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- I2989174
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- I3118242
- I3146037
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- I2648686
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- I3014361
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- I3031156
- I3074776
- I3079112
- I3098976
- I3184893
- I3199765
- I3200769
- I3213959
- I3234851
- I3298682
- I3310672
- I3333092
- IN4904
- I2794465
- I2827044
- I2903555
- I2917182
- I2921920
- I2976566
- I3001144
- I3014363
- I3023712
- I3074778
- I3079113
- I3098978
- I3118245
- I3146044
- I3186053
- I3195193
- I3200770
- I3232085
- I3282785
- I3298683
- IN4905
- I2622058
- I2639679
- I2648688
- I2693458
- I2719968
- I2738935
- I2755250
- I2755251
- I2770154
- I2834504
- I2853629
- I2868611
- I2903558
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- I2933526
- I2937707
- I2989176
- I3001145
- I3031157
- I3056444
- I3079114
- I3085682
- I3129679
- I3146045
- I3161252
- I3185199
- I3204106
- I3245241
- I3262834
- I3333094
- IN4906
- I2607469
- I2617783
- I2639671
- I2648689
- I2657813
- I2669871
- I2684462
- I2693459
- I2808575
- I2834502
- I2839306
- I2903559
- I2933527
- I2989177
- I3014364
- I3023714
- I3056449
- I3065880
- I3085683
- I3097700
- I3146046
- I3204104
- I3213967
- I3282786
- IN4907
- I2684550
- I2707738
- I2707741
- I2747546
- I2770153
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- I2812829
- I2819771
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- I2868612
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- I2903561
- I2917184
- I2933528
- I2976568
- I2976569
- I3001146
- I3014365
- I3014366
- I3065280
- I3074779
- I3098979
- I3129680
- I3146047
- I3213979
- I3248082
- I3282787
- IN4908
- I2623336
- I2654504
- I2684552
- I2794463
- I2839307
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- I2903564
- I2988261S1
- I2989180
- I3043208
- I3056451
- I3098980
- I3129681
- I3204100
- I3232095
- I3262837
- IN4909
- I2639691
- I2684549
- I2693461
- I2853630
- I2858652
- I2891843
- I2915034
- I2921921
- I2927918
- I2989178
- I3014368
- I3023715
- I3031158
- I3056452
- I3098981
- I3110572
- I3146048
- I3161258
- I3204105
- I3226196
- I3232116
- I3248083
- I3282789
- I3298686
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- IN4911
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- I2773993
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- I2921923
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- I2927921
- I2933529
- I2976570
- I2989184
- I3014369
- I3014370
- I3023716
- I3031159
- I3031160
- I3053785
- I3056454
- I3057825
- I3097703
- I3118246
- I3129682
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- I2684547
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- I2933534
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- I3275918
- I3310676
Allwell Inflation Device, for angiographic use REF: IS-30-A
- UDI-DI
- 00884450653500
- Lot code
- I2559701
- I2563344
- I2567488
- I2578111
- I2593681
- I2593683
- I2603907
- I2617788
- I2622059
- I2628990
- I2653159
- I2657407
- I2853633
- I2887859
- I2887860
- I2892046
- I2917191
- I2921522
- I2927924
- I2933535
- I2989185
- I2989187
- I3027377
- I3027378
- I3037369
- I3085686
- I3085687
- I3103552
- I3118248
- I3118249
- I3154769
- I3186052
- I3186054
- I3186058
- I3214004
- I3245239
- I3245240
- I3248078
- I3282794
Allwell Angioplasty Pack REF: IS-30-B1/B
- UDI-DI
- 00884450653388
- Lot code
- I2563105
- I2563106
- I2565007
- I2598114
- I2598131
- I2607891
- I2612499
- I2618005
- I2623057
- I2632527
- I2632528
- I2639728
- I2661908
- I2669772
- I2669774
- I2827091
- I2827094
- I2844360
- I2844361
- I2897482
- I2897483
- I2897484
- I2897485
- I2924663
- I2972425
- I2972426
- I2972427
- I2972428
- I2999054
- I3014683
- I3030198
- I3048363
- I3055799
- I3080949
- I3089230
- I3099150
- I3110034
- I3129711
- I3129712
- I3161408
- I3268359
- I3268361
- I3268362
Merit Medical , Custom Manifold Kit REF: K09-13203A
- UDI-DI
- 00884450479964
- Lot code
- H2671718
- H2681531
- H2758436
- H2792533
- H2796074
- H3046979
- H3052442
- H3147779
- H3246149
- H3254530
- H3297407
Recall details
- Company began the recall
- Sold in
Worldwide - Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, VI, Vermont, Washington, Wisconsin, West Virginia, Wyoming, 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.
- Company
- Merit Medical Systems, Inc.South Jordan, Utah
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98139
- Recall numbers
- Z-1123-2026 to Z-1129-2026
All recalls from Merit Medical Systems, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
