{"url_path":"/fda/device/recalls/Z-2320-2026","section_key":"summary","section_title":"DEVICE Recall: BERLIN HEART GMBH — EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2320-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"BERLIN HEART GMBH"},"word_count":87,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2320-2026\n\n**Recalling firm:** BERLIN HEART GMBH\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-24\n**Report date:** 2026-06-17\n\n## Product\nEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01\n\n## Reason\nBlood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.\n\n## Affected lots\nREF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254\n\n## Distribution\nUS Nationwide distribution in the states of MA, SC."}