# FDA recall Z-1697-2025

> **Vyaire Medical** · Class I · device recall initiated 2025-04-10.

## Product

Brand Name: AirLife  Product Name: AirLife Infant Heated Wire Circuit  Model/Catalog Number: AH165  Software Version: N/A  Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)  Component: No.  a conduit for respiratory gas between the patient and a ventilator.

## Reason for recall

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

## Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

## Key facts

- **Recall number:** Z-1697-2025
- **Recalling firm:** Vyaire Medical
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-10
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mettawa, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2025

## Citation

> AI Analytics. FDA recall Z-1697-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1697-2025. Source: US FDA. Licensed CC0.

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