# FDA recall Z-0360-2024

> **Avanos Medical, Inc.** · Class II · device recall initiated 2023-10-13.

## Product

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

## Reason for recall

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

## Distribution

US and South Africa

## Key facts

- **Recall number:** Z-0360-2024
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-13
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0360-2024

## Citation

> AI Analytics. FDA recall Z-0360-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0360-2024. Source: US FDA. Licensed CC0.

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