FDA Device recall Z-0059-2025
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angio…
- 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 MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angio… 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-0059-2025 |
| 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 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.
Reason
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Identifiers
| code_info | Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880…Catalog Number: IN2330/B UDI-DI code: 00884450298046 Lot Number: H2369557 H2416390 H2421992 H2426112 H2492843 H2522880 H2540015 H2554505 H2560208 H2579556 H2765640 H2793109 H2806018 H2810777 |
|---|
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-0059-2025%22
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