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Medline Cardiac Procedure Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Cardiac Procedure Kits

Medline is recalling cardiac procedure kits to clarify that the included chest drainage units are intended for adult patients only.

What to do

Review the updated instructions for use to ensure the device is only used for patients 18 years and older. Contact Medline or your healthcare provider if you have questions regarding the appropriate patient population for these kits.

Recalled
Listed
Updated
Recall No.
Z-1562-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98437
Status
ONGOING

Recall at a glance

Quantity recalled
2894 units

Why it was recalled

Medline is recalling specific cardiac procedure kits containing Cardinal Health Aqua-Seal Chest Drainage Units because the instructions for use have been updated to clarify that the devices are intended only for patients 18 years and older. The affected kits include the Open Heart kit, Cardiac Procedure kit, and Cardio Congenito kit.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductModel
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEARTDYNJ902487A
CARDIAC PROCEDUREDYNJ908126
CARDIO CONGENITODYNJ910851

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification