FDA recall, , Moderate risk
Medline Open Heart, Cardiac Procedure and Cardio Congenito Kits
The chest drainage units have updated instructions to clarify they are for adults only.
Summary by Recall Canary from the FDA notice
What happened
Medline Industries, LP, of Northfield, Illinois, recalled Medline Kits containing Cardinal Health's Aqua-Seal Chest Drainage Unit, including the OPEN HEART model DYNJ902487A, the CARDIAC PROCEDURE model DYNJ908126, and the CARDIO CONGENITO model DYNJ910851.
The instructions for use on the chest drainage units were updated to clarify the intended target patient population as adults, 18 years and older. The recall began on January 30, 2026, and was added to the FDA's Enforcement Report on March 12, 2026.
The recalled units were distributed in the state of California and the countries of Chile and Panama.
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 your kit affected?
Affected if its model number, UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) Open Heart
- Model
- DYNJ902487A
- UDI-DI
- 10193489496635
- 40193489496636
- 10193489980110
- 40193489980111
- 10198459155895
- 40198459155896
- Lot code
- 22KMG297
- 22FMA481
- 21IMG797
- 21HMG569
- 21HMB801
- 26ABL637
- 25JBN467M
- 25JBN467
- 25JBG183
- 25HBF488
- 25GBK350
- 25FBO822
- 25EBT976
- 25EBP602
- 25EBP589
- 25EBP588
- 25EBP587
- 25EBP586
- 25DBB810
- 25ABA001
- 24HBM020
- 24GBC436
- 24FBS256
- 24BBP532
- 24BBA256
- 24ABN040
- 23JBP214
- 23JBJ077
- 23IBQ646
- 23HBU475
- 23GBE710
- 23GBE709
- 23FBF593
- 23DBJ852
- 23DBC954
- 22KBO714
- 25IBK435
- 25HBT069
- 25HBO806
- 25HBH137
- 25GBA989
- 24LBJ019
Cardiac Procedure
- Model
- DYNJ908126
Cardio Congenito
- Model
- DYNJ910851
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the state of California and the countries of Chile, Panama.
- Company
- Medline Industries, LPNorthfield, 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
- 98437
- Recall number
- Z-1562-2026
- Quantity recalled
- 2894 units
All recalls from Medline Industries, LP
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
Summary updated
