Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0060-2025 — 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

U.S. FDA — Device Enforcement · United States · 2024-08-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0060-2025
Date of alert: 2024-08-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merit Medical Systems, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00884450298053

Reported risk: Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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