{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217863", "product_res_number": "Z-1486-2026", "event_date_initiated": "2026-01-23", "event_date_posted": "2026-03-03", "recall_status": "Open, Classified", "res_event_number": "98189", "product_code": "DSP", "k_numbers": [ "K031636", "K172305" ], "product_description": "CS100 IABP. Software Version CS100 IABP Q.01.", "code_info": "All Model No; All UDI; All Serial No.", "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 firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE CORRECTION notice dated January 2026 was mailed to consignees. The notification informs consignees of an updated battery specification to be updated in the IFU. Consignees are to forward the notice to all users in their facility, confirm users are aware of the IFU clarifications, and complete and return the provided Response Form. If product was further distributed, the provided notification is to be forwarded to them. Consignees with any questions should contact Datascope/Getinge Cusotmer Support at 1-888-943-8872, options 4, 2, 1.", "product_quantity": "10,897 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador , Estonia, France, Georgia, Germany, Ghana, Greece, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.", "openfda": { "k_number": [ "K810297", "K811372", "K181122", "K892799", "K020257", "K961358", "K770821", "K832753", "K112372", "K894942", "K896597", "K963104", "K823739", "K831307", "K893243", "K863185", "K860427", "K980780", "K070225", "K840367", "K840037", "K963920", "K970689", "K780280", "K031636", "K981660", "K914802", "K993966", "K002949", "K932268", "K062582", "K855102", "K010330", "K813182", "K896430", "K880289", "K963187", "K905663", "K830411", "K190117", "K863219", "K882508", "K120868", "K903769", "K924382", "K853062", "K936232", "K813355", "K903893", "K943919", "K813023", "K952576", "K864568", "K790755", "K974247", "K133074", "K973962", "K903892", "K112327", "K960713", "K945230", "K950687", "K844220", "K820166", "K833828", "K896497", "K864994", "K031569", "K801601", "K994157", "K940178", "K021462", "K903736", "K954431", "K892797", "K232343", "K860638", "K962177", "K903867", "K972113", "K900281", "K041281", "K831397", "K971673", "K192238", "K920427", "K892798", "K903930", "K790775", "K864567", "K013326", "K942454", "K002256", "K922235", "K892878", "K963865", "K201112", "K874816", "K910997", "K982538", "K082746", "K831235", "K821065", "K895433", "K915580", "K122628", "K940231", "K833632", "K940298", "K905056", "K882274", "K926000", "K040801", "K864537", "K875036", "K903917", "K965209", "K190101", "K781848", "K162820", "K892222", "K925248", "K200634", "K172305", "K823342", "K902057", "K820882", "K921638", "K903344", "K965236", "K063525", "K850482", "K802924", "K802167", "K821951", "K830410", "K060309", "K913847", "K983866", "K823177", "K905313", "K911000", "K091449", "K952221", "K960166", "K003598", "K980850", "K964987", "K790241", "K980385", "K896920", "K250542", "K935184", "K151254", "K163542", "K904018", "K904414", "K944460", "K000729", "K961509", "K912629", "K760695" ], "registration_number": [ "3008496839", "2032677", "3009077524", "3013596024", "2183744", "2249723", "3002807314", "2518435", "9681477", "2031093", "2126666", "1319639", "3010041511", "3010532612", "3013320573", "3024894463", "3015859709", "3000126629", "2248146", "3007965489", "3013162291", "1061124", "9610816", "9680794", "3003263092", "3013500228", "3010155661", "2011171" ], "fei_number": [ "3008496839", "1000512168", "3009077524", "1000138054", "3013596024", "2183744", "3003945344", "3002807314", "2518435", "2126666", "3010041511", "3010532612", "3002807439", "3013320573", "3024894463", "3015859709", "3000126629", "1000222374", "3001236549", "3007965489", "3013162291", "3001418283", "3003263092", "3013500228", "3003737899", "3010155661", "2011171", "3002807167" ], "device_name": "System, Balloon, Intra-Aortic And Control", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3535", "device_class": "2" } } ] }