Chest Drainage Units and Accessories: Product Code Description 1 — Class II medical device recall Z-1203-2026
Ongoing recall by Cardinal Health 200, LLC, reported 2026-02-04, distributed nationwide. The firm is updating the IFU to clarify the intended patient population for the identified chest drainage unit
| Recall number | Z-1203-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2025-12-26 |
| Classified | 2026-01-28 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CL, CO, DO, MX |
| Quantity | 1,169,726 units |
| UPC / GTIN / UDI-DI | 10192253002294, 10192253002300, 10192253002645, 10192253002652, 10192253002669, 10192253003017, 10192253003024, 10192253003031, 10192253003062, 10192253003079, 10192253003086, 10192253003093, 50192253002292, 50192253002308, 50192253002643, 50192253002650, 50192253002667, 50192253003015, 50192253003022, 50192253003039, 50192253003060, 50192253003077, 50192253003084, 50192253003091 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1203-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.