# FDA recall Z-1522-2025

> **Avanos Medical, Inc.** · Class I · device recall initiated 2025-03-19.

## Product

Brand Name: Ballard  Product Name: Closed Suction Catheters  Model/Catalog Number: 210  Software Version: N/A  Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow  Component: N/A

## Reason for recall

Lack of sterility assurance for closed suction catheter systems

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN,KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, 	TX, UT, VA, WA, WI and the countries of South Korea, New Zealand,  Canada,  Mexico, Germany, England, Slovenia, France, Austria, Guadalajara.

## Key facts

- **Recall number:** Z-1522-2025
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-19
- **Report date:** 2025-04-23

- **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-1522-2025

## Citation

> AI Analytics. FDA recall Z-1522-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1522-2025. Source: US FDA. Licensed CC0.

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