⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-04-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Reason / hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-02-25
Code info
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Product quantity
39 units
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98599
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