Quick Facts at a Glance
- Recall Date
- December 26, 2025
- Hazard Level
- HIGH
- Brand
- Cardinal Health 200
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cardinal Health 200
- Product type
- Chest Drainage Units
- Model numbers
- All units affected by IFU update. UDI-DI: 1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7. 8888571315 Cardinal Health Aqua-Seal CDU +9 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 26, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
Chest drainage units are medical devices used to remove air or fluid from the pleural space in patients. They are critical in treating conditions such as pneumothorax and pleural effusion, primarily used in hospital settings.
Why This Is Dangerous
The hazard arises when these units are used on infants, as they may not show expected signs of functionality, leading to misinterpretation by healthcare providers. This can delay necessary treatment, resulting in complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may affect patient treatment plans and requires immediate action from healthcare providers and patients to prevent potential health risks.
Practical Guidance
How to identify if yours is affected
- Verify the product code on your chest drainage unit against the recall list.
- Check the packaging and any accompanying documentation for the IFU details.
- Consult with your healthcare provider if you are unsure about the product's status.
Where to find product info
Product codes can usually be found on the device packaging or on the unit itself near the barcode or labeling.
What timeline to expect
Expect processing of refunds or returns within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication with Cardinal Health.
- Follow up via phone or email if no response is received within a week.
How to prevent similar issues
- Always check for product recalls before using medical devices.
- Ensure devices are suitable for the intended patient population, especially in pediatrics.
Documentation advice
Keep a record of your purchase, including receipts and correspondence with Cardinal Health regarding the recall.
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Product Details
The recall affects several models, including Cardinal Health Sentinel Seal CDU and Thora-Seal devices, with product codes ranging from 8888571562 to 8884713900. These units were distributed globally, including the US, Brazil, Canada, and Mexico.
Key Facts
- Recall Date: December 26, 2025
- Distribution: US and several Latin American countries
- Classification: Class II
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Safety Guide
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