{"recall":{"id":"fda-device-99148","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Penumbra, Inc. recalls Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT","firm":"Penumbra, Inc.","date":"2026-06-03","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT","code":"UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038","quantity":"N/A","number":"Z-2770-2026","classification":"Class II"}],"reason":"Due to manufacturing issues, reperfusion catheters may fractures","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - 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.","nationwide":true,"states":[],"units":"N/A","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=99148","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"4eb0c36f823b7ca6","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=99148","record":[{"status":"Ongoing","city":"Livermore","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99148","recalling_firm":"Penumbra, Inc.","address_1":"6262 Patterson Pass Rd Ste A","address_2":"N/A","postal_code":"94550-9576","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - 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.","recall_number":"Z-2770-2026","product_description":"Penumbra System RED 68 Reperfusion Catheter  REF: RED68KIT","product_quantity":"N/A","reason_for_recall":"Due to manufacturing issues,  reperfusion catheters may fractures","recall_initiation_date":"20260603","center_classification_date":"20260721","report_date":"20260729","code_info":"UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038"}]}}