Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA)
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
Recall record
- Recalling firm
- Cardinal Health 200, LLC
- Product type
- Devices
- Recall number
- Z-1203-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Waukegan, IL
- Recall initiated
- 2025-12-26
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1203-2026 · Source: openFDA enforcement.