Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal… — Class II medical device recall Z-0060-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2024-10-23, distributed nationwide. Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
| Recall number | Z-0060-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-08-30 |
| Classified | 2024-10-11 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CA, FR, GB, JP, NL, QA |
| Quantity | 6,565 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00884450298053 |
| Lot numbers | 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 and 27 more |
| Model numbers | IN2430, IN2430/B |
Product
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.
Reason for recall
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0060-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.