{ "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": "221095", "product_res_number": "Z-2887-2026", "event_date_initiated": "2026-06-08", "event_date_posted": "2026-08-05", "recall_status": "Open, Classified", "res_event_number": "99226", "product_code": "JTN", "k_numbers": [ "K253105" ], "product_description": "HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435\n\n\nHardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,", "code_info": "Catalog Number: Z9435\nUD-DI code: Pending\nLot Number: 543461", "firm_fei_number": "2022807", "recalling_firm": "Hardy Diagnostics", "address_1": "1430 W McCoy Ln", "city": "Santa Maria", "state": "CA", "postal_code": "93455-1005", "additional_info_contact": "Caley Thompson\n805-346-2766 Ext. 5786", "reason_for_recall": "Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.", "root_cause_description": "Under Investigation by firm", "action": "On 06/08/2026 an \"URGENT: Medical Device Recall Notification\" was sent via First Class Mail and Email and/or Facsimile to customer informing them that as a result of receiving a customer complaint/report, it was confirmed that antibiotic disk cartridges labeled as HardyDisk AST Cefiderocol (disk code FDC30) were found to contain sporadic disks labeled with Piperacillin/Tazobactam disk code (TZP110).\n\nCustomers are instructed to:\n1. Discard any remaining stock.\n2. Response to this notification is requested within 5 business days of receipt of this letter, either through mail or email. To respond by mail, complete, sign, and send the enclosed inventory reconciliation form (FORM-2023C) via USPS First Class Mail. To respond by email, scan and send the completed inventory reconciliation form (FORM-2023C) to TechnicalServices@HardyDiagnostics.com.\n3. Replacements will be sent out at no-charge to your laboratory or a credit will be applied to invoice upon request.\n\nFor Questions - contact Technical Services Department at (800) 266-2222, option 2 or via email at TechnicalServices@HardyDiagnostics.com.", "product_quantity": "43 units", "distribution_pattern": "U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.", "openfda": { "k_number": [ "K870347", "K964493", "K971635", "K193508", "K870175", "K943407", "K860895", "K892721", "K052853", "K843725", "K812524", "K812993", "K870348", "K994212", "K920787", "K812783", "K000829", "K000203", "K992853", "K892727", "K000526", "K893754", "K890344", "K860527", "K082272", "K982526", "K812228", "K850957", "K232276", "K000930", "K002165", "K801473", "K170127", "K822832", "K850606", "K002367", "K992077", "K000272", "K922791", "K864756", "K992507", "K982517", "K895392", "K892719", "K000201", "K873829", "K182357", "K000304", "K963845", "K850357", "K871674", "K000302", "K842292", "K963508", "K992646", "K183298", "K261781", "K992420", "K203336", "K994150", "K971638", "K821264", "K850607", "K855206", "K813441", "K001487", "K050062", "K994132", "K231806", "K892733", "K011086", "K003556", "K241060", "K973479", "K203700", "K930946", "K902082", "K001728", "K152846", "K964491", "K100722", "K930702", "K925060", "K892714", "K810427", "K002369", "K965159", "K924766", "K003686", "K833416", "K860536", "K994046", "K973488", "K891772", "K002368", "K821262", "K894829", "K922793", "K974578", "K851622", "K003690", "K000181", "K852873", "K002660", "K193504", "K982528", "K924765", "K011384", "K994134", "K192326", "K994129", "K961819", "K971637", "K003554", "K892729", "K982520", "K800540", "K964495", "K802178", "K892713", "K000928", "K994051", "K932052", "K801474", "K852689", "K921420", "K955669", "K253105", "K080019", "K892726", "K000130", "K062245", "K964512", "K830731", "K000261", "K010536", "K080998", "K103538", "K003532", "K992562", "K251337", "K210873", "K993994", "K251879", "K921193", "K970385", "K873707", "K984513", "K874256", "K971632", "K822809", "K823800", "K832653", "K010537", "K922794", "K892735", "K933118", "K992546", "K992568", "K760701", "K961188", "K810546", "K920131", "K992076", "K910506", "K112586", "K002656", "K971631", "K964490", "K872938", "K833414", "K892728", "K070262", "K964501", "K830956", "K001490", "K842253", "K852835", "K813387", "K940359", "K994063", "K152838", "K874425", "K864848", "K262113", "K980683", "K250885", "K982669", "K992717", "K002662", "K832515", "K931290", "K060286", "K892720", "K052876", "K833415", "K983718", "K811377", "K870870", "K971120", "K920786", "K842252", "K994089", "K020842", "K982523", "K822394", "K842307", "K921282", "K250789", "K892715", "K992647", "K832909", "K812994", "K892724", "K961818", "K000022", "K830732", "K002661", "K982524", "K892723", "K812571", "K930911", "K870201", "K982235", "K000305", "K191931", "K920473", "K872783", "K935975", "K250956", "K172621", "K000259", "K002663", "K000440", "K812916", "K892717", "K934100", "K843172", "K000762", "K970830", "K852967", "K093807", "K831153", "K000183", "K931289", "K993186", "K925969", "K971633", "K981517", "K924846", "K984036", "K900344", "K855135", "K261853", "K964496", "K221826", "K865034", "K973489", "K980955", "K821229", "K001489", "K923952", "K181975", "K895679", "K964421", "K971211", "K000258", "K000268", "K000525", "K812525", "K993993", "K910412", "K971636", "K994067", "K230827", "K992593", "K924797", "K892730", "K171975", "K994091", "K833709", "K860153", "K931799", "K982519", "K892718", "K000524", "K993577", "K812844", "K000509", "K972098", "K082271", "K000128", "K964492", "K994135", "K944275", "K831179", "K230651", "K152516", "K892725", "K042157", "K260842", "K002664", "K973487", "K832956", "K801648", "K970212", "K000175", "K003536", "K970831", "K933657", "K850358", "K003537", "K974394", "K964487", "K011385", "K984608", "K000271", "K992297", "K250454", "K802194", "K810564", "K851228", "K964489", "K181700", "K820019", "K000182", "K992726", "K231568", "K832910", "K931530", "K892722" ], "pma_number": [ "N60242" ], "registration_number": [ "3035367039", "1119779", "8020667", "3013661582", "2030652", "2022807", "2647876", "8010096", "3004111573", "2032112", "3012389632" ], "fei_number": [ "4247", "3035367039", "1119779", "3013661582", "3000205059", "3003076831", "2022807", "3006224287", "3004111573", "2647876", "3012389632" ], "device_name": "Susceptibility Test Discs, Antimicrobial", "medical_specialty_description": "Microbiology", "regulation_number": "866.1620", "device_class": "2" } } ] }