{ "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": "218716", "product_res_number": "Z-1587-2026", "event_date_initiated": "2026-02-06", "event_date_posted": "2026-03-19", "recall_status": "Open, Classified", "res_event_number": "98432", "product_code": "DSP", "k_numbers": [ "K112372" ], "product_description": "Battery Charging Station;\nModel: 0998-00-0802;", "code_info": "Model: 0998-00-0802;\nUDI: 10607567111964;\nSerial Numbers: 200019347EAI, 200019847EAI, 200019447EAI, 210018625EAI, 210017925EAI, 210017525EAI, 210018425EAI, 210020144EAI, 210020944EAI, 210022544EAI, 210020244EAI, 210022144EAI, 210020044EAI, 210020544EAI, 210021344EAI, 210023244EAI, 210018025EAI, 210019025EAI, 210021144EAI, 210021044EAI, 210022344EAI, 210019225EAI, 210019125EAI, 210018525EAI, 210022844EAI, 200017647EAI, 210019725EAI, 210022744EAI;", "firm_fei_number": "3001418283", "recalling_firm": "Datascope Corp.", "address_1": "1300 Macarthur Blvd", "city": "Mahwah", "state": "NJ", "postal_code": "07430-2052", "additional_info_contact": "Stephanie Howard\n201-995-8701", "reason_for_recall": "The Battery Charging Station is an optional dual-bay\ncharger used to charge the Cardiosave IABP Lithium-\nIon batteries when they are not being used to\noperate the IABP. Getinge has identified that a\nprotruding screw in the left battery bay limits full\ninsertion of certain batteries and prevents proper\ncharging. The right bay of the Battery Charging\nStation is not affected by this issue.", "root_cause_description": "Under Investigation by firm", "action": "On February 6, 2026 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers.\nActions to be taken by the customer:\nOur records indicate that you may have one or more Battery Charging Station(s) in your facility. Please forward this\ninformation to all current Battery Charging Station users within your facility.\n\" If you are currently using one of the affected Battery Charging Stations, please follow the instructions in the\nBattery Charging Instructions section of this letter.\n\" Complete and sign the attached Response Form to acknowledge that you have received and understand\nthis notification. Return the completed form to recallresponses.grc@getinge.com.\nIf you are a distributor who has shipped any affected products to customers, please forward this document to their\nattention for appropriate action.", "product_quantity": "28 units (20 US, 8 OUS)", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of FL, DC, GA, IL, IN, MD, MI, NC, TX, WA, WI and the countries of Australia, Hong Kong, Israel, Japan, Norway.", "openfda": { "k_number": [ "K924382", "K903344", "K936232", "K902057", "K963187", "K892797", "K960713", "K961509", "K980385", "K040801", "K760695", "K963920", "K905056", "K950687", "K840037", "K831397", "K192238", "K823177", "K863185", "K082746", "K940178", "K000729", "K913847", "K982538", "K940298", "K810297", "K830411", "K882508", "K903892", "K965236", "K940231", "K904018", "K850482", "K875036", "K091449", "K163542", "K120868", "K943919", "K893243", "K993966", "K780280", "K922235", "K920427", "K903893", "K892798", "K912629", "K965209", "K002949", "K864537", "K813355", "K041281", "K903930", "K190117", "K813023", "K790755", "K980780", "K831235", "K151254", "K060309", "K790775", "K896430", "K921638", "K781848", "K900281", "K915580", "K802924", "K896920", "K994157", "K860638", "K911000", "K914802", "K892222", "K892878", "K801601", "K903867", "K823342", "K880289", "K945230", "K973962", "K981660", "K972113", "K830410", "K820882", "K823739", "K905313", "K903917", "K964987", "K021462", "K971673", "K860427", "K010330", "K853062", "K961358", "K954431", "K802167", "K895433", "K003598", "K960166", "K070225", "K122628", "K903736", "K831307", "K894942", "K905663", "K963865", "K944460", "K926000", "K980850", "K833632", "K813182", "K904414", "K833828", "K031636", "K201112", "K974247", "K864568", "K821065", "K190101", "K963104", "K181122", "K952221", "K970689", "K112327", "K983866", "K062582", "K892799", "K863219", "K770821", "K935184", "K232343", "K031569", "K250542", "K002256", "K133074", "K932268", "K112372", "K896497", "K882274", "K952576", "K925248", "K910997", "K874816", "K864567", "K864994", "K840367", "K172305", "K844220", "K896597", "K013326", "K162820", "K200634", "K020257", "K832753", "K962177", "K063525", "K811372", "K820166", "K942454", "K855102", "K821951", "K903769", "K790241" ], "registration_number": [ "9681477", "3010532612", "2031093", "3013500228", "9610816", "1061124", "9680794", "3008496839", "3010155661", "2518435", "3000126629", "3013162291", "1319639", "2183744", "2126666", "3024894463", "3002807314", "2032677", "3009077524", "2249723", "2248146", "3003263092", "3010041511", "3013320573", "3013596024", "3007965489", "3015859709", "2011171" ], "fei_number": [ "3010532612", "3013500228", "3008496839", "3010155661", "2518435", "3000126629", "3013162291", "3003945344", "3001418283", "2183744", "3002807167", "2126666", "3024894463", "3002807314", "1000138054", "3009077524", "3001236549", "3003737899", "3002807439", "3003263092", "1000222374", "3010041511", "3013320573", "1000512168", "3013596024", "3007965489", "3015859709", "2011171" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }