Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AVANOS BALLARD Closed Suction System for Adults Recalled by Avanos Medical, Inc. Due to Certain lots of BALLARD Closed Suction System for...

Date: October 13, 2023
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

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

Quantity: 4730 cases (94600 devices)

Why Was This Recalled?

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.

Where Was This Sold?

US and South Africa

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