{"url_path":"/fda/device/recalls/Z-2625-2026","section_key":"summary","section_title":"DEVICE Recall: Hamilton Medical AG — IntelliCuff, Portable automatic cuff pressure controller  REF: 951001","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-22","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2625-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Hamilton Medical AG"},"word_count":120,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2625-2026\n\n**Recalling firm:** Hamilton Medical AG\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-22\n**Report date:** 2026-07-08\n\n## Product\nIntelliCuff, Portable automatic cuff pressure controller  REF: 951001\n\n## Reason\nDue to reported complaints, the cuff device may alarm with a \"Cuff System Leakage\" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.\n\n## Affected lots\nGTIN: 07630002800839/ Lot # range: 00001 -19732\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, \tND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada."}