{"url_path":"/fda/device/recalls/Z-2770-2026","section_key":"summary","section_title":"DEVICE Recall: Penumbra, Inc. — Penumbra System RED 68 Reperfusion Catheter  REF: RED68KIT","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-03","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2770-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Penumbra, Inc."},"word_count":128,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2770-2026\n\n**Recalling firm:** Penumbra, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-03\n**Report date:** 2026-07-29\n\n## Product\nPenumbra System RED 68 Reperfusion Catheter  REF: RED68KIT\n\n## Reason\nDue to manufacturing issues,  reperfusion catheters may fractures\n\n## Affected lots\nUDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038\n\n## Distribution\nWorldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates."}