{"url_path":"/fda/device/recalls/Z-1855-2026","section_key":"summary","section_title":"DEVICE Recall: Intuitive Surgical, Inc. — Intuitive 8 mm SureForm 30 Gray Reloads   Reference Numbers: 48230M-05 and 48230M-06","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1855-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Intuitive Surgical, Inc."},"word_count":137,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1855-2026\n\n**Recalling firm:** Intuitive Surgical, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-11\n**Report date:** 2026-05-13\n\n## Product\nIntuitive 8 mm SureForm 30 Gray Reloads   Reference Numbers: 48230M-05 and 48230M-06\n\n## Reason\nReloads for curved-tipped stapler may potentially produce an incomplete staple line.\n\n## Affected lots\nUDI:00886874121931/All serial Numbers\n\n## Distribution\nUS: Alabama\tAlaska\tArizona\tArkansas\tCalifornia\tColorado\tConnecticut\tDelaware\tDistrict of Columbia\tFlorida\tGeorgia\tHawaii\tIdaho\tIllinois\tIndiana\tIowa\tKansas\tKentucky\tLouisiana\tMaine\tMaryland\tMassachusetts\tMichigan\tMinnesota\tMississippi\tMissouri\tMontana\tNebraska\tNevada\tNew Hampshire\tNew Jersey\tNew Mexico\tNew York\tNorth Carolina\tNorth Dakota\tOhio\tOklahoma\tOregon\tPennsylvania\tSouth Carolina\tSouth Dakota\tTennessee\tTexas\tUtah\tVermont\tVirginia\tWashington\tWest Virginia\tWisconsin  OUS: Austria\tBelgium\tDenmark\tFinland\tFrance\tGermany\tIreland\tItaly\tJapan\tNetherlands\tNorway\tSpain\tSweden\tSwitzerland\tUnited Kingdom"}