Lower risk Medical device recall · FDA · Published October 13, 2023

Avanos Ballard Closed Suction System Recall: DEHP Contamination Risk

Avanos recalls specific lots of Ballard Closed Suction Systems for adults due to DEHP contamination in tubing. Affected units may pose health risks if used on patients. Contact Avanos for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0360-2024Medical device Avanos ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmAvanos Medical, Inc.5405 Windward Pkwy · Alpharetta, GA 30004-3894

✎ GovInfoNow plain-language explainer

Avanos is recalling certain lots of their Ballard Closed Suction System for adults because the tubing contains DEHP, a chemical that can be harmful. This risk is especially concerning for patients on mechanical ventilation who use the suction system. Read more at govinfonow.com/recall/57074-avanos-ballard-closed-suction-system-recall-dehp-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/57074-avanos-ballard-closed-suction-system-recall-dehp-contamination-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0360-2024

Cite this page

“Avanos Ballard Closed Suction System Recall: DEHP Contamination Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57074-avanos-ballard-closed-suction-system-recall-dehp-contamination-risk. Based on FDA recall #Z-0360-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0360-2024%22&limit=1).

The FDA announced on 2023-10-13 that Avanos Medical, Inc. is recalling AVANOS BALLARD Closed Suction System for Adults due to incorrect labeling regarding Di(2-ethylhexyl) phthalate (DEHP). The company determined that tubing components contained DEHP despite labels stating otherwise.

How to tell if you have it

Brand: Avanos
Product: AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI
Product code: 221038
UDI/DI: 00609038945064
Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991
Quantity: 4730 cases (94600 devices)
Distribution: US and South Africa

The hazard

Certain lots of the BALLARD Closed Suction System for Adults were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP), but Avanos determined that the tubing components did contain DEHP. The FDA classified this recall as Class II.

Context

GovInfoNow's records show Avanos Medical, Inc. has had 18 other recalls on record since 2019-10-08. Other recent recalls of similar products include Covidien Shiley Disposable Decannulation Plug Recall (2026-04-23), Medline Medical Kits Recall (2025-12-16) and Medline medical procedure kits with Strykeflow 2 irrigation leak risk - recall (2025-12-16).

How to tell if you have this one

Check for the product code 221038 and lot numbers listed: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991. The product is used for adults on mechanical ventilation.

Brand
Avanos
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product code 221038 and lot numbers listed in the recall notice to determine if your unit is affected.

How this recall unfolded

Recall timeline

FDA published this recall 47 days after the firm started it.

Oct 13, 2023Firm started the recall
Nov 20, 2023FDA classified it Class II
Nov 29, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57074-avanos-ballard-closed-suction-system-recall-dehp-contamination-risk">Avanos Ballard Closed Suction System Recall: DEHP Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0360-2024 (October 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0360-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.