Notice names this product. BERLIN HEART’s EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves is named in FDA Class II recall Z-2320-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Units affected: 3. Status: Ongoing.
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.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
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.
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Company / brand: BERLIN HEART recalls
Affected product: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves recall status
Official ID Z-2320-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.