CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Monarch Inflation Device 30 atm/bar recalled by Merit Medical Systems
Merit Medical Systems is recalling Monarch Inflation Device 30 atm/bar, distributed nationwide in the US. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0057-2025
- FDA event ID
- 95330
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2024
- FDA classified
- 11 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 30 Aug 2024 | Recall initiated by company | |
| 11 Oct 2024 | Classified by FDA | +42 days |
| 23 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95330This product is part of a recall event; the main page for the event is Melrose Wakefield Hospital recalled by Merit Medical Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Melrose Wakefield Hospital recalled by Merit Medical Systems | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large recalled | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis recalled | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis recalled | Merit Medical Systems | Sterility | Nationwide | |
| CLASS II | Monarch Inflation Device MAP 112 Access-9 Large Bore recalled | Merit Medical Systems | Sterility | Nationwide |
More recalls from Merit Medical Systems
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|---|---|---|---|---|---|
| Device | CLASS II | Splashwire Hydrophilic Guide Wire recalled by Merit Medical Systems | Merit Medical Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS II | Philips Bridge Prep Kit recalled by Merit Medical Systems | Merit Medical Systems | Other | Nationwide |
| Device | CLASS I | DuraMax Chronic Hemodialysis Catheter recalled by Merit Medical Systems | Merit Medical Systems | Device Malfunction | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |