FDA recall, , Moderate risk
Cardinal Health Chest Drainage Units and Accessories
Chest drainage units may not show tidaling or bubbling when used on infants, which could lead to inadequate treatment.
Summary by Recall Canary from the FDA notice
What happened
Cardinal Health 200, LLC, of Waukegan, Illinois, is recalling Chest Drainage Units and Accessories because the firm is updating the Instructions for Use (IFU) to clarify that the intended patient population is adults, 18 years and older.
When used on infants, the chest drainage unit (CDU) may not demonstrate tidaling or bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate or inappropriate treatment or therapy, delay to treatment or therapy, and prolonged hospitalization. The recall began on December 26, 2025, and was added to the FDA's Enforcement Report on January 28, 2026.
The affected products include the Cardinal Health Sentinel Seal CDU, Sentinel Seal CDU Dual Drain, Sentinel Seal CDU with Easy Change Connector, Altitude CDU Dry Suction with Easy Change Connector, Aqua-Seal CDU Wet Suction, and Aqua-Seal CDU Wet Suction Dual Drain. The products were distributed nationwide in the US and to Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Chest Drainage Units and Accessories
- UDI-DI
- 8888571562
- 50192253003091
- 10192253003093
- 8888571513
- 50192253003084
- 10192253003086
- 8888571489
- 50192253003077
- 10192253003079
- 8888571370
- 50192253003039
- 10192253003031
- 8888571299
- 50192253003015
- 10192253003017
- 8888571406
- 50192253003060
- 10192253003062
- 8888571315
- 50192253003022
- 10192253003024
- 8884713100
- 50192253002643
- 10192253002645
- 1814713105
- 50192253002308
- 10192253002300
- 1180571570
- 50192253002292
- 10192253002294
- 8884713308
- 50192253002650
- 10192253002652
- 8884713900
- 50192253002667
- 10192253002669
- Lot code
- 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 details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
- Company
- Cardinal Health 200, LLCWaukegan, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98228
- Recall number
- Z-1203-2026
- Quantity recalled
- 1,169,726 units
All recalls from Cardinal Health 200, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
