Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve… — Class II medical device recall Z-0059-2025

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-0059-2025`
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	1,120 devices
Reason classes	sterility
UPC / GTIN / UDI-DI	`00884450298046`
Lot numbers	`H2369557`, `H2416390`, `H2421992`, `H2426112`, `H2492843`, `H2522880`, `H2540015`, `H2554505`, `H2560208`, `H2579556`, `H2765640`, `H2793109`, `H2806018`, `H2810777`
Model numbers	`IN2330`, `IN2330/B`

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 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-0059-2025. 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.