{ "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": "2026-10-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221920", "product_res_number": "Z-3331-2026", "event_date_initiated": "2026-07-24", "event_date_posted": "2026-09-29", "recall_status": "Open, Classified", "res_event_number": "99591", "product_code": "NRY", "k_numbers": [ "K203440", "K250690" ], "product_description": "Brand Name: Penumbra System (RED 62 Reperfusion Catheter)\r\nProduct Name: Penumbra System (RED 62 Reperfusion Catheter)\r\nModel/Catalog Number: THNDRRED62SKIT\r\nSoftware Version: N/A\r\nProduct Description: Product common name: Percutaneous catheter\r\n\r\nA complete product description is provided in Attachment 1 (HHE-2026-002 RED62).\r\nComponent: Penumbra System", "code_info": "Lot Code: UDI: 00815948024359\rLot Number: H00007856", "firm_fei_number": "3005168196", "recalling_firm": "Penumbra Inc.", "address_1": "1 Penumbra 1", "city": "Penumbra Alameda", "state": "CA", "postal_code": "94502-7610", "additional_info_contact": "Shruthi Narayan\n+1-765-7023892", "reason_for_recall": "Due to manufacturing issues reperfusion catheters may fracture.", "root_cause_description": "Under Investigation by firm", "action": "On 07/24/2026, an \"URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION\" was sent via email and FedEx Priority Overnight to customers informing them that Penumbra has identified an issue (frature) in the lot H00007856 of the Penumbra System RED 62 Reperfusion Catheter (RED 62).\n\nActions Customers need to take:\n\"\nShare this Recall Notification with all users of the product within your facility\n\"\nReview inventory for the specified lot listed above\n\"\nIf you do have inventory of the specified lot listed above, remove affected units from inventory and place in quarantine for return to Penumbra, Inc. Complete and return the Product Identification/Return Notification to notifications@penumbrainc.com within 3 business days. Your Penumbra Sales Representative will work with you directly to arrange return and credit.\n\"\nIf you do not have inventory of the specified lot listed above, complete and return the Product Identification/Return Notification form to notifications@penumbrainc.com within 3 business days. No further action is required.\n\nFor questions - contact Penumbra Sales Representative or email at notifications@penumbrainc.com.", "product_quantity": "43", "distribution_pattern": "US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.", "openfda": { "k_number": [ "K193063", "K033736", "K242504", "K173761", "K223530", "K180705", "K183464", "K233329", "K230695", "K132641", "K180008", "K201689", "K220808", "K232971", "K191768", "K183043", "K262398", "K061059", "K062046", "K090085", "K240917", "K190464", "K261089", "K211654", "K252392", "K243080", "K210996", "K233988", "K182522", "K251357", "K190010", "K211476", "K250012", "K260617", "K122478", "K211338", "K142458", "K173200", "K251603", "K223545", "K212908", "K063774", "K191946", "K211411", "K152541", "K232524", "K141491", "K160641", "K251015", "K262399", "K253062", "K251006", "K250690", "K100769", "K160449", "K181354", "K141516", "K203440", "K150616", "K190338", "K093610", "K161064", "K070521", "K123378", "K113163", "K250958", "K241221", "K133464", "K222808", "K090752", "K161640", "K211120", "K243948", "K153071", "K182101", "K243047", "K120961", "K143077", "K242672", "K251789", "K243601", "K202251", "K173452", "K172448", "K173841", "K183185", "K203592", "K252046", "K172167", "K151623", "K254276", "K251828", "K113455", "K252707", "K221934", "K072718", "K223913", "K133317", "K071172", "K260002", "K202182", "K222786", "K230429", "K253590", "K190212", "K161879", "K262391", "K211697", "K193380", "K243287", "K234083", "K081305", "K162901", "K242104", "K082034" ], "registration_number": [ "3031288142", "3014590708", "3008837339", "3003144120", "3013656790", "3015453963", "3020954126", "1220477", "3015701715", "3015531723", "3014644549", "3016678045", "1721676", "3021520400", "3007628272", "2030624", "3014590707", "2029214", "3012543881", "3014211783", "3027319104", "3009337401", "3009957947", "3008853977", "2011171", "3012931345", "3011370111", "9616664", "3014162263", "3007007790", "3010079067", "3008264254", "3015615738", "2024311", "3016522967", "3021009035", "3014498720", "3016591327", "3039020025", "3019807891", "3008824097", "2183744", "3017168767", "1721504", "3008881809", "2183828", "3016540856", "3009380063", "3013758550", "3030088112", "3010034260", "3009546466", "3012497308", "3022392708", "3006451981", "1048735", "3013556777", "3008114965", "3015550451", "3002807314", "3005168196" ], "fei_number": [ "3031288142", "3014590708", "3008837339", "3013656790", "3015453963", "3020954126", "1220477", "3009024869", "3015701715", "3015531723", "3014644549", "3016678045", "1721676", "3021520400", "3007628272", "3014590707", "3012543881", "3014211783", "3027319104", "3009337401", "3004099094", "3009957947", "1000220862", "3008853977", "2011171", "3000206435", "3012931345", "3011370111", "3014162263", "3007007790", "3010079067", "3008264254", "3015615738", "2024311", "3016522967", "3021009035", "3014498720", "3016591327", "3039020025", "3019807891", "3008824097", "2183744", "3017168767", "1721504", "3008881809", "2183828", "3016540856", "3009380063", "3013758550", "3030088112", "3010034260", "3009546466", "3012497308", "3022392708", "3006451981", "1048735", "3013556777", "3008114965", "3015550451", "3002807314", "3005168196" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }