FDAClass II · Medical device · Recall Z-1838-2026 · Recalled April 29, 2026

Medline Kits recall — Medline Industries, LP

Agency report date: April 29, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Medline Kits
Company / brand: Medline Industries
Lot / serial / date codes: 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Distribution: US Nationwide distribution.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Medline Kits

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1838-2026
Brand: Medline Industries
Classification: Class II
Units affected: 39 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Medline Kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98599
Recall initiated: February 25, 2026
FDA classified: April 17, 2026
FDA report date: April 29, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved July 28, 2026 at 11:00 PM UTC.

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