BERLIN HEART recalls

Recall found. BERLIN HEART is named in FDA Class II recall Z-2320-2026 covering EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves. Hazard: Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. Identifying details: REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254. Status: Ongoing.

Models with recalls

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves (1)

All BERLIN HEART recalls

FDA Class II · Medical device · June 17, 2026

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves recall — BERLIN HEART GMBH

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Official ID Z-2320-2026 · Official record ↗

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USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.