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Home › FDA recalls › Medline Kits: 1) HEART TRANSPLANT BIOPSY
CLASS II · ModerateFDA

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

📅 Feb 25, 2026 · 📍 Nationwide
Recalling company
Medline Industries, LP
Product
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 25, 2026
Reported
Apr 29, 2026
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
39 units
Lot / codes
1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-1838-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1838-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.