{"recall":{"id":"fda-device-99591","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Ca","firm":"Penumbra Inc.","date":"2026-07-24","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System","code":"Lot Code: UDI: 00815948024359 Lot Number: H00007856","quantity":"43","number":"Z-3331-2026","classification":"Class II"}],"reason":"Due to manufacturing issues reperfusion catheters may fracture.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.","nationwide":true,"states":[],"units":"43","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99591","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e7a1ae41d0933a5c","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99591","record":[{"status":"Ongoing","city":"Alameda","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99591","recalling_firm":"Penumbra Inc.","address_1":"1 Penumbra","address_2":"","postal_code":"94502-7610","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.","recall_number":"Z-3331-2026","product_description":"Brand Name: Penumbra System (RED 62 Reperfusion Catheter)  Product Name: Penumbra System (RED 62 Reperfusion Catheter)  Model/Catalog Number: THNDRRED62SKIT  Software Version: N/A  Product Description: Product common name: Percutaneous catheter    A complete product description is provided in Attachment 1 (HHE-2026-002 RED62).  Component: Penumbra System","product_quantity":"43","reason_for_recall":"Due to manufacturing issues reperfusion catheters may fracture.","recall_initiation_date":"20260724","center_classification_date":"20260929","report_date":"20261007","code_info":"Lot Code: UDI: 00815948024359 Lot Number: H00007856","more_code_info":""}]}}