High risk Medical DevicesClass II

Medline Medical Procedure Kits Recall

MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A;

Updated May 4, 2026

Medline Medical Procedure Kits used in cardiac and vascular surgeries have defects in catheter quality, including surface irregularities, loose connectors, and diameter problems that could affect patient safety during critical procedures.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on May 4, 2026. Details below.

What is recalled

Medline Medical Procedure Kits: 1) BASIC HEART PACK (SKU DYNJ67331B); 2) CARDIAC SURGERY (SKU DYNJ911589A); 3) CAROTID ENDARTERECTOMY (SKU DYNJ36211D); 4) CHLA ECMO / CARDIAC PACK (SKU DYNJ87973 and DYNJ87973A); 5) CV PART 1 AND 2 (SKU DYNJ908879 and DYNJ908879C); 6) FEM POP CDS (SKU CDS983670K); 7) LAP BASIN TRAY (SKU DYNJ50908B); 8) OPEN HEART LTX CATHETERS KIT (SKU DYNJ0049032A); 9) OPEN HEART PACK (SKU DYNJ80549C and DYNJ80549D); 10) RR-ADULT ECMO PACK (SKU DYNJ69742B); 11) TAVR (SKU DYNJ906509C).

Am I affected

You are affected if your healthcare facility received or used any of these Medline Medical Procedure Kits with the SKU numbers listed above for cardiac, vascular, or ECMO procedures.

What to do right now

If you received or used any of these kits, stop use immediately and contact Medline Industries, LP or your hospital supply chain to report receipt and arrange for replacement.

The hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2486-2026
Classification
Class II
Recalled
May 4, 2026
Read the official notice

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