{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220948", "product_res_number": "Z-2770-2026", "event_date_initiated": "2026-06-03", "event_date_posted": "2026-07-21", "recall_status": "Open, Classified", "res_event_number": "99148", "product_code": "NRY", "k_numbers": [ "K211411" ], "product_description": "Penumbra System RED 68 Reperfusion Catheter\nREF: RED68KIT", "code_info": "UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038", "firm_fei_number": "3013758550", "recalling_firm": "Penumbra, Inc.", "address_1": "6262 Patterson Pass Rd Ste A 6262 Patterson Pass Rd", "address_2": "Ste A", "city": "Livermore", "state": "CA", "postal_code": "94550-9576", "additional_info_contact": "Shruthi Narayan\n+1-765-7023892", "reason_for_recall": "Due to manufacturing issues, reperfusion catheters may fractures", "root_cause_description": "Under Investigation by firm", "action": "On June 2, 2026, Penumbra issued a Urgent Medical Device Recall Notification to affecte consignees via FedEx. Penumbra asked consignees to take the following actions:\n\n1. Review inventory and remove affected units from inventory and place in quarantine for return. \n\n2.Complete and return the response form to notifications@penumbrainc.com. Your Penumbra representative will work with you directly to arrange return and credit of affected devices. If you do not have any affected product, please still complete the response form and return. \n\n3. Share recall notification with all users of the product within your facility.", "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.", "openfda": { "k_number": [ "K193380", "K190010", "K182101", "K161640", "K072718", "K203592", "K262399", "K120961", "K033736", "K211654", "K242504", "K252707", "K232524", "K161879", "K251357", "K201689", "K132641", "K250012", "K251789", "K252046", "K211697", "K190464", "K061059", "K113455", "K233988", "K173200", "K150616", "K243047", "K262398", "K172448", "K070521", "K260002", "K254276", "K211338", "K190338", "K133464", "K141516", "K090085", "K243080", "K212908", "K220808", "K142458", "K180705", "K100769", "K221934", "K243601", "K153071", "K152541", "K241221", "K222808", "K250690", "K262391", "K133317", "K160449", "K211476", "K203440", "K183464", "K141491", "K211411", "K182522", "K093610", "K071172", "K191946", "K161064", "K183185", "K082034", "K173452", "K151623", "K222786", "K190212", "K162901", "K253590", "K123378", "K233329", "K243287", "K253062", "K211120", "K251015", "K183043", "K243948", "K081305", "K250958", "K173761", "K230695", "K143077", "K173841", "K191768", "K193063", "K234083", "K113163", "K202251", "K172167", "K252392", "K063774", "K223545", "K090752", "K180008", "K240917", "K210996", "K223913", "K242104", "K242672", "K232971", "K260617", "K122478", "K181354", "K251006", "K223530", "K230429", "K251828", "K251603", "K160641", "K202182", "K062046" ], "registration_number": [ "3012543881", "2030624", "3030088112", "3012497308", "3009546466", "3007628272", "3009380063", "3013656790", "3008837339", "3020954126", "3013758550", "3039020025", "3014498720", "3031288142", "3005168196", "3003144120", "1048735", "3006451981", "3009337401", "3015550451", "3015701715", "3010079067", "3015531723", "3013556777", "3008114965", "3016591327", "3014590707", "3016522967", "3012931345", "2183744", "2029214", "3010034260", "3002807314", "3008881809", "3008824097", "3014162263", "3016540856", "3016678045", "3014644549", "1721676", "3008264254", "3007007790", "2183828", "3021520400", "1220477", "3009957947", "3022392708", "3008853977", "3019807891", "9616664", "3011370111", "2024311", "3014211783", "3015615738", "3014590708", "3017168767", "3015453963", "2011171", "1721504", "3021009035" ], "fei_number": [ "3012543881", "3030088112", "3000206435", "3012497308", "3009546466", "3007628272", "3009380063", "3013656790", "3008837339", "3020954126", "3013758550", "3039020025", "3014498720", "3031288142", "3005168196", "1048735", "3006451981", "3009337401", "3015550451", "3015701715", "3010079067", "3015531723", "1000220862", "3013556777", "3008114965", "3016591327", "3014590707", "3016522967", "3012931345", "2183744", "3010034260", "3004099094", "3002807314", "3008881809", "3008824097", "3014162263", "3016540856", "3016678045", "3014644549", "1721676", "3008264254", "3007007790", "2183828", "3021520400", "1220477", "3009957947", "3022392708", "3008853977", "3009024869", "3019807891", "3011370111", "2024311", "3014211783", "3015615738", "3014590708", "3017168767", "3015453963", "2011171", "1721504", "3021009035" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }