FDAFDA · Food and drugs·Recall number Z-1838-2026
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Published April 29, 2026 · Recall initiated: February 25, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- US Nationwide distribution.
- Lot
- 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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