Class II FDA device recall · Z-1126-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

Inflation device handle may detach from the syringe during procedure.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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.

Recall record

Recalling firm: Merit Medical Systems, Inc.
Product type: Devices
Recall number: Z-1126-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: South Jordan, UT
Recall initiated: 2025-12-04

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1126-2026 · Source: openFDA enforcement.