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Medline Heart Transplant Biopsy Kit (Model DYNJ37543A) is being withdrawn because certain components, Control Syringes, Guidewires, and/or High-Pressure Tubing, no longer have valid regulatory clearance.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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1838-2026
- Classification
- Class II
- Recalled
- February 25, 2026
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