{"url_path":"/fda/device/recalls/Z-2773-2026","section_key":"summary","section_title":"DEVICE Recall: Micro Therapeutics,  Inc. — Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027  REF PED2-300-12","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-08","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2773-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Micro Therapeutics,  Inc."},"word_count":104,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2773-2026\n\n**Recalling firm:** Micro Therapeutics,  Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-08\n**Report date:** 2026-07-29\n\n## Product\nPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027  REF PED2-300-12\n\n## Reason\nIncorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.\n\n## Affected lots\nUDI: 00763000448806/ Lot: D062612, D112860\n\n## Distribution\nUS Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, \tWA."}