Lower risk Medical device recall · FDA · Published August 30, 2024

Merit Medical Melrose Wakefield Hospital 30 ATM Injector Recall: Tyvek Barrier Holes Risk

Merit Medical recalls Melrose Wakefield Hospital 30 ATM angiographic injectors due to Tyvek barrier holes that could allow contamination. Affected units have specific lot numbers and were sold between 2021-2023.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0062-2025Medical device Merit Medical ›

Lower-risk recall

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Take action

Contact the company

Recalling firmMerit Medical Systems, Inc.1600 W Merit Pkwy · South Jordan, UT 84095-2416

✎ GovInfoNow plain-language explainer

Merit Medical is recalling its Melrose Wakefield Hospital 30 ATM angiographic injectors because manufacturing defects created holes in the Tyvek sterile barrier. This could allow contaminants to enter the device during medical procedures, potentially causing infections. Read more at govinfonow.com/recall/54132-merit-medical-melrose-wakefield-hospital-30-atm-injector-recall-tyvek.

Source Summary by GovInfoNow · govinfonow.com/recall/54132-merit-medical-melrose-wakefield-hospital-30-atm-injector-recall-tyvek · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0062-2025

Cite this page

“Merit Medical Melrose Wakefield Hospital 30 ATM Injector Recall: Tyvek Barrier Holes Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54132-merit-medical-melrose-wakefield-hospital-30-atm-injector-recall-tyvek. Based on FDA recall #Z-0062-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2025%22&limit=1).

The FDA announced on August 30, 2024, that Merit Medical Systems is recalling the Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe due to holes in the sterile barrier. The agency classified this as a Class II recall of 432 devices distributed worldwide.

How to tell if you have it

Brand: Merit Medical
Product: Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe
Catalog Number: K05T-02159
UDI-DI code: 00884450140840
Lot Numbers: T2417859, T2434208, T2509792, T2549931, T2561788, T2625814, T2675576, T2762716, T2801089, T2893877
Quantity: 432 devices

The hazard

The recall is due to a manufacturing process resulting in holes or breaches in the Tyvek sterile barrier. The FDA said this defect could compromise the sterility of the device used to inflate and deflate balloon angioplasty catheters.

Context

GovInfoNow's records show Merit Medical Systems, Inc has issued 37 other recalls since February 24, 2006. Other recent recalls of similar products include the Embosphere 500-700 Micrometer Syringe Recall (August 10, 2026) and the Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026). Additional related recalls involve the Philips Bridge Prep Kit (April 2, 2026), Vortex Surgical 25GA I.D.D. Device (December 16, 2025), Vortex Surgical I2 Injection Kit (December 16, 2025), and Medtronic GUNDRY Cannula (April 21, 2026).

How to tell if you have this one

Check for the product name 'Melrose Wakefield Hospital REF K05T-2159' on the device. Look for lot numbers: T2417859 through T2893877. These units were sold between 2021 and 2023.

Brand
Merit Medical
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Belgium, Canada, France, Japan, Monaco, Netherlands, Qatar, United Arab Emirates, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-0057-2025	Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: IN2130/B UDI-DI code: 00884450298022 Lot Number: H2298616 H2305036 H2309344 H2320983 H2326311 H2331539 H2337133 H2343847 H2348708 H2353509 H2360153 H2363096 H2369555 H2379873 H2385821 H2385822 H2390615 H2395794 H2398306 H2398307 H2413093 H2416389 H2421990 H2426109 H2426110 H2432438 H2435891 H2435892 H2443005 H2443006 H2446111 H2446112 H2453677 H2457935 H2457936 H2462761 H2466451 H2474178 H2474381 H2478395 H2483315 H2486954 H2492842 H2497958 H2503845 H2507121 H2511931 H2517519 H2522879 H2528488 H2534959 H2540013 H2545412 H2550517 H2554636 H2560207 H2564558 H2568223 H2574050 H2579555 H2584202 H2589844 H2594942 H2599816 H2604241 H2610525 H2614055 H2618905 H2622810 H2629606 H2633300 H2639297 H2645652 H2649895 H2655508 H2660064 H2664660 H2669777 H2673568 H2673571 H2682478 H2688023 H2689404 H2701288 H2709365 H2721312 H2724409 H2733388 H2739474 H2746747 H2751182 H2755942 H2760545 H2761569 H2765632 H2769986 H2774664 H2774665 H2779111 H2789790 H2793108 H2819815 H2824760 H2830071 H2838428 H2838429 H2845202 H2847851 H2849886 H2856553 H2861490 H2867259 H2867398 H2871516 H2877375 H2886249 H2890795 H2900796 H2907141 H2912642 H2918427 H2925193 H2929404 H2934698 H2937984 H2943477 H2972585 H2982494 H3000024 Catalog Number: IN2130/JPB UDI-DI code: 00884450298022 Lot Number: H2298077 H2311498 H2318440 H2326018 H2335950 H2348220 H2361952 H2378902 H2397943 H2446311 H2457899 H2466518 H2511623 H2538830 H2617878 H2632026 H2645098 H2709628 H2721346 H2739491 H2746832 H2756147 H2765723 H2770192 H2790666 H2799040 H2806169 H2838478 H2845266 Catalog Number: K05-02130 UDI-DI code: 00884450047248 Lot Number: H2304639 H2326198 H2353301 H2360131 H2412972 H2443283 H2454607 H2473435 H2503267 H2516468 H2673631 H2708526 H2751266 H2756101 H2856665	110,650 devices
Z-0058-2025	Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: IN2230/B UDI-DI code: 00884450298039 Lot Number: H2287420 H2292343 H2298614 H2305033 H2309342 H2312490 H2320981 H2326309 H2331538 H2337132 H2343845 H2348707 H2353507 H2360151 H2379871 H2385818 H2395792 H2398304 H2413090 H2416387 H2421986 H2432426 H2435878 H2442961 H2446109 H2453675 H2457933 H2458274 H2466447 H2474177 H2478393 H2483314 H2486956 H2492840 H2497955 H2503844 H2507119 H2511930 H2517517 H2522877 H2528486 H2540011 H2545410 H2550516 H2554634 H2560206 H2564557 H2568221 H2574048 H2579553 H2584200 H2589842 H2594940 H2599814 H2604238 H2610524 H2614052 H2618903 H2622808 H2629605 H2633298 H2639295 H2645646 H2649893 H2655505 H2660061 H2664662 H2669779 H2673553 H2675990 H2683251 H2701290 H2709357 H2713928 H2733074 H2739475 H2746858 H2751186 H2760546 H2765638 H2789805 H2819396	41,411 devices
Z-0059-2025	Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777	1,120 devices
Z-0060-2025	Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: IN2430/B UDI-DI code: 00884450298053 Lot Number: H2298615 H2305035 H2309343 H2320982 H2326310 H2353508 H2369554 H2385820 H2395793 H2398305 H2413092 H2416388 H2421988 H2426107 H2432428 H2435884 H2442968 H2446110 H2453676 H2457934 H2462756 H2466450 H2478394 H2486953 H2492841 H2497956 H2507120 H2517518 H2522878 H2528487 H2540012 H2545411 H2554635 H2568222 H2574049 H2579554 H2584201 H2589843 H2594941 H2599815 H2614054 H2618904 H2622809 H2633299 H2639296 H2645647 H2649894 H2655507 H2660062 H2664663 H2669780 H2673558 H2697508 H2713941 H2733075 H2746745 H2751196 H2765642 H2806015 H2815182 H2819813 H2834412 H2842698 H2849884 H2861491 H2907143 H2918428	6,565 devices
Z-0061-2025	Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: IN2530/B UDI-DI code: 00884450298060 Lot Number: H2305037 H2309345 H2312492 H2320984 H2326312 H2331540 H2337135 H2343848 H2348709 H2353510 H2379875 H2385823 H2398320 H2413098 H2416393 H2421995 H2426129 H2432439 H2435893 H2443007 H2446113 H2453678 H2457937 H2458275 H2466457 H2474179 H2483316 H2486955 H2492844 H2497959 H2503846 H2507122 H2511932 H2517520 H2522881 H2528489 H2534960 H2540016 H2545413 H2550521 H2554673 H2560209 H2564559 H2568225 H2574051 H2579557 H2584204 H2594880 H2594944 H2599817 H2604242 H2610526 H2614059 H2618906 H2622811 H2629607 H2633301 H2639298 H2645654 H2649898 H2655509 H2660065 H2664666 H2669781 H2672437 H2673582 H2683311 H2688025 H2693066 H2703591 H2713947 H2733076 H2746748 H2751197 H2760547 H2769987 H2774666 H2784537 H2789807 H2793110 H2801750 H2806027 H2810778 H2824764 H2834413 H2838430 H2845204 H2847853 H2849888 H2849889 H2856554 H2861492 H2867260 H2871518 H2880698 H2890797 H2907144 H2912644 H2918429 H2925194 H2929405 H2934699 H2937986 H2943479 H2978085 H2982496 H2989541 H2994311 H3000025 H3009570	51,900 devices
Z-0062-2025	Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.; Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877	432 devices

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers T2417859 through T2893877 on the device packaging or label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 states.

FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 54 days after the firm started it.

Aug 30, 2024Firm started the recall
Oct 11, 2024FDA classified it Class II
Oct 23, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54132-merit-medical-melrose-wakefield-hospital-30-atm-injector-recall-tyvek">Merit Medical Melrose Wakefield Hospital 30 ATM Injector Recall: Tyvek Barrier Holes Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0062-2025 (August 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0062-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.