Recall Z-1525-2025— Avanos Medical, Inc.

Name: FDA recall Z-1525-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-19

Class I · Ongoing

Class I FDA medical device recall by Avanos Medical, Inc., initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A. Reason: Lack of sterility assurance for closed suction catheter systems.

Recalling firm: Avanos Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-03-19
Firm location: Alpharetta, GA, United States

Product description

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A

Reason for recall

Lack of sterility assurance for closed suction catheter systems

Data sourced from openFDA. This site is unofficial and independent of the FDA.