{"url_path":"/fda/device/recalls/Z-2312-2026","section_key":"summary","section_title":"DEVICE Recall: ICU Medical, Inc. — Plum Duo Infusion Pump, 40002-0401","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2312-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ICU Medical, Inc."},"word_count":106,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2312-2026\n\n**Recalling firm:** ICU Medical, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-29\n**Report date:** 2026-06-17\n\n## Product\nPlum Duo Infusion Pump, 40002-0401\n\n## Reason\nUnder certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.\n\n## Affected lots\nUDI-DI M335400021 Plum Duo Infusion Pump v1.2.3\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada."}