{"id":"515406a0-c0b7-4106-a942-559de3a867af","slug":"fda-recall-intuitive-ion-2026","filingNumber":"Z-1134-2026","filingType":"fda_recall","jurisdiction":"us_fda","applicantCompanyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","filingDate":"2025-12-04T12:00:00.000Z","decisionDate":"2026-01-28T12:00:00.000Z","status":"recalled","clearanceScope":"Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue.","sources":[{"url":"https://api.fda.gov/device/recall.json?search=product_res_number:Z-1134-2026","title":"FDA recall Z-1134-2026","sourceName":"openFDA (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-05T16:55:33.556Z","updatedAt":"2026-06-05T18:22:52.958Z","applicantCompany":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","slug":"intuitive-surgical","name":"Intuitive Surgical"},"modelLinks":[{"id":"ad7a4a55-fbd8-4509-b4bf-96891a44aca1","modelId":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","regulatoryFilingId":"515406a0-c0b7-4106-a942-559de3a867af","createdAt":"2026-06-05T17:43:06.374Z","model":{"slug":"intuitive-ion","modelName":"Ion Endoluminal System"}}]}