Avanos Medical, Inc.: Device Recall

Recall #Z-1527-2025 · 03/19/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1527-2025
Classification
Class I
Product Type
Device
Recalling Firm
Avanos Medical, Inc.
Status
Ongoing
Date Initiated
03/19/2025
Location
Alpharetta, GA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1040 units

Reason for Recall

Lack of sterility assurance for closed suction catheter systems

Product Description

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A

Distribution Pattern

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.

Other Recalls by Avanos Medical, Inc.

View all recalls by Avanos Medical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.