medical MODERATE Updated 2026-04-29

Medline Industries, LP recalls Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYN

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Recalled Product

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

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Hazard / Issue

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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