Chest drainage unit instructions updated to specify adult patient population
Medline is recalling three surgical kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify the target patient population as adults.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the recall updates the instructions for use to clarify the intended patient population, and the source describes no defect in the devices.
Plain-English summary
Medline Industries, LP is recalling Medline kits containing Cardinal Health's Aqua-Seal Chest Drainage Unit: Open Heart (model DYNJ902487A), Cardiac Procedure (DYNJ908126) and Cardio Congenito (DYNJ910851). About 2,894 units were distributed in California and to Chile and Panama. The FDA has classified this recall as Class II.
The instructions for use on the specified Cardinal Health Chest Drainage Units and accessories have been updated to clarify the intended target patient population as adults, 18 years and older. The source record does not describe a defect or malfunction in the devices themselves.
Each model carries its own UDI-DI and lot numbers, listed in the FDA enforcement record.
Facilities can identify affected kits by the model numbers, UDIs and lot codes, and may contact Medline Industries, LP for further information.
The recalled product
- Product
- Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Chest drainage
- Affected units
- 2,894
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNJ902487A
- UDI-DI: 10193489496635(each)
- 40193489496636(case)
- Lot Number: 22KMG297
- 2) DYNJ902487A
- Lot Number: 22FMA481
- 3) DYNJ902487A
- Lot Number: 21IMG797
- 4) DYNJ902487A
- Lot Number: 21HMG569
- 5) DYNJ902487A
- Lot Number: 21HMB801
- 6) DYNJ908126
- UDI-DI: 10193489980110(each)
- 40193489980111(case)
- Lot Number: 26ABL637
- 7) DYNJ908126
- Lot Number: 25JBN467M
- 8) DYNJ908126
- Lot Number: 25JBN467
Distribution
Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · documentation update
See all →- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips C9-4 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips Mini Multi TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
Similar recalls
- HighChest drainage units recalled to limit their use to adults
FDA (Devices) · 2026-02-04
- HighMedline Cardiac Surgery Kits Recalled Due to Sterilization Equipment Calibration Issues
FDA (Devices) · 2026-05-13
- HighMedline open heart and cardiac kits contain catheters failing specifications
FDA (Devices) · 2026-06-24
- SevereMedline Surgical Kits Recalled Due to Rescinded Regulatory Clearances
FDA (Devices) · 2026-04-29
- HighMedline cardiovascular draping and basin kits contain substandard catheters
FDA (Devices) · 2026-06-24
- SevereMedline medical procedure kits with Medtronic Aortic Root Cannula recalled
FDA (Devices) · 2025-04-16