FDAHealthFebruary 25, 2026
Medline Industries, LP — Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
⚠️ The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 25, 2026
US Nationwide distribution.
What's affected?
- Product
- Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
- Lot code
- 24DDA193
Additional details
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 39 units.
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