Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: Recalled by Avanos Medical, Inc. Due to Lack of sterility assurance for closed suction catheter...

Date: March 19, 2025
Company: Avanos Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Avanos Medical, Inc. directly.

Affected Products

Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A

Quantity: 9960 units

Why Was This Recalled?

Lack of sterility assurance for closed suction catheter systems

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Avanos Medical, Inc.

Avanos Medical, Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report