Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Healt...
FDA Device Recall #Z-1203-2026 - Class II, December 26, 2025
Recall Summary
| Recall Number | Z-1203-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 26, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cardinal Health 200, LLC |
| Location | Waukegan, IL |
| Product Type | Devices |
| Quantity | 1,169,726 units |
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
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)
Other Recalls from Cardinal Health 200, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1768-2026 | Class II | Cardinal Health Monoject Tuberculin Syringe, 1 ... | Feb 27, 2026 |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Descript... | Nov 12, 2025 |
| Z-0207-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0208-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0211-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.