FDA Device recall Z-0057-2025
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe i…
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe i… by Merit Medical Systems, citing due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0057-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-30 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
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.
Reason
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Identifiers
| code_info | Catalog Number: IN2130/B UDI-DI code: 00884450298022 Lot Number: H2298616 H2305036 H2309344 H2320983 H2326311 H2331539…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0057-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.