{"id":"732fc73e-f12b-4427-a68d-fca151946144","slug":"fda-recall-intuitive-ion-flexison-needle-2021","filingNumber":"Z-0106-2022","filingType":"fda_recall","jurisdiction":"us_fda","applicantCompanyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","filingDate":"2021-08-06T12:00:00.000Z","decisionDate":"2021-10-20T12:00:00.000Z","status":"recalled","clearanceScope":"Intuitive Ion Endoluminal System Flexison biopsy needle (19G, REF 490104-09 / 49004-10): sheath tip on the biopsy needle may separate from the sheath shaft. FDA Class II.","sources":[{"url":"https://api.fda.gov/device/enforcement.json?search=recall_number:Z-0106-2022","title":"FDA recall Z-0106-2022","sourceName":"openFDA (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":"985cc77b-b062-41c9-8f0e-f2c436c2b64f","reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-05T18:22:51.848Z","updatedAt":"2026-06-05T18:22:51.848Z","applicantCompany":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","slug":"intuitive-surgical","name":"Intuitive Surgical"},"modelLinks":[{"id":"e65c1696-541a-4c88-a35b-2da4f0560e2a","modelId":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","regulatoryFilingId":"732fc73e-f12b-4427-a68d-fca151946144","createdAt":"2026-06-05T18:22:51.934Z","model":{"slug":"intuitive-ion","modelName":"Ion Endoluminal System"}}]}