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Medline Heart Transplant Biopsy Kit Recall

Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A

Updated February 25, 2026

Medline Heart Transplant Biopsy Kit (Model DYNJ37543A) is being withdrawn because certain components, Control Syringes, Guidewires, and/or High-Pressure Tubing, no longer have valid regulatory clearance. Healthcare facilities should verify the status of their kits with Medline.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on February 25, 2026. Details below.

What is recalled

Medline Heart Transplant Biopsy Kit, Model Number DYNJ37543A, including Control Syringes, Guidewires, and High-Pressure Tubing components.

Am I affected

You are affected if your healthcare facility uses Medline Heart Transplant Biopsy Kit Model DYNJ37543A. Check your equipment inventory for this specific model number.

What to do right now

Stop using this kit immediately. Contact Medline Industries, LP directly to arrange for a replacement or guidance on discontinuing use.

The hazard

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Brands affected

Medline Industries, LP
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1838-2026
Classification
Class II
Recalled
February 25, 2026
Read the official notice

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