Use caution Medical device recall · FDA · Published December 26, 2025

Cardinal Health Chest Drainage Units: Risk of Incorrect Use in Infants

Cardinal Health recalls chest drainage units for adults only; using on infants may cause treatment delays and prolonged hospitalization due to lack of tidaling/bubbling.

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

🇺🇸 FDA recall #Z-1203-2026Medical device Cardinal Health ›

Use caution until it’s fixed

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Take action

Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337

✎ GovInfoNow plain-language explainer

Cardinal Health is recalling chest drainage units and accessories that are intended for adults 18 and older. Using these on infants could lead to incorrect treatment assessments, delays in care, and longer hospital stays because the units may not show proper function indicators. Read more at govinfonow.com/recall/50337-cardinal-health-chest-drainage-units-risk-of-incorrect-use-in.

Source Summary by GovInfoNow · govinfonow.com/recall/50337-cardinal-health-chest-drainage-units-risk-of-incorrect-use-in · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1203-2026

Cite this page

“Cardinal Health Chest Drainage Units: Risk of Incorrect Use in Infants.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50337-cardinal-health-chest-drainage-units-risk-of-incorrect-use-in. Based on FDA recall #Z-1203-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2026%22&limit=1).

Cardinal Health 200, LLC recalled chest drainage units and accessories worldwide on Dec. 26, 2025, the FDA said. The firm is updating instructions to clarify the intended patient population as adults 18 years and older.

How to tell if you have it

Brand: Cardinal Health
Product Code 8888571562 Cardinal Health Sentinel Seal CDU
Product Code 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain
Product Code 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector
Product Code 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector
Product Code 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction
Product Code 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain
Product Code 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector
Product Code 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL
Product Code 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)
Product Code 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL
Product Code 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL
Product Code 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

The hazard

When used on infants, the units may not demonstrate tidaling or bubbling, which can confound clinician assessment of device functionality. This may lead to inadequate or inappropriate treatment, delay to therapy, and prolonged hospitalization.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 58 other recalls on record since 2017-06-27. Other recent recalls of similar products include Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (2026-08-18), Presource Convenience Kits (2026-08-10), and Presource Packs with Contaminated Wipes (2026-07-29). Medline recalled Aqua-Seal Chest Drainage Units for Adults Only on 2026-01-30.

How to tell if you have this one

Check for product codes listed in the recall: 8888571562, 8888571513, 8888571489, 8888571370, 8888571299, 8888571406, 8888571315, 8884713100, 1814713105, 1180571570, 8884713308, 8884713900. These units were sold for adults only but may be used on infants.

Brand
Cardinal Health
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Codes
Identify if your chest drainage unit has one of the listed product codes (e.g., 8888571562) from the recall list.
Verify Intended Use
Ensure the device is only used on patients aged 18 years or older as per the updated instructions.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Dec 26, 2025Firm started the recall
Jan 28, 2026FDA classified it Class II
Feb 4, 2026Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Check the product code on your device. If it matches the recalled list, ensure it is only used on patients aged 18 or older. No return or replacement is required as the hazard is about correct use, not a defect.

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Link to this recall

<a href="https://govinfonow.com/recall/50337-cardinal-health-chest-drainage-units-risk-of-incorrect-use-in">Cardinal Health Chest Drainage Units: Risk of Incorrect Use in Infants (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-1203-2026 (December 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1203-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.