{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130736", "product_res_number": "Z-0196-2015", "event_date_initiated": "2014-10-10", "event_date_posted": "2014-11-07", "recall_status": "Terminated", "event_date_terminated": "2015-06-26", "res_event_number": "69472", "product_code": "GDC", "k_numbers": [ "K090136" ], "product_description": "The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.", "code_info": "5085 and 5085SRT", "firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "Kathryn Cadorette\n440-392-7601", "reason_for_recall": "The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.", "root_cause_description": "Device Design", "action": "STERIS will mail Consignee Notification Letters to the affected Consignees via FedEx with tracking numbers for delivery confirmation. The Consignee Notification mailing will initiate the week of October 13, 2014.", "product_quantity": "999", "distribution_pattern": "US distribution: AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI. Foriegn: Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.", "openfda": { "k_number": [ "K850168", "K843134", "K964273", "K851021", "K851830", "K883613", "K934744", "K970807", "K853480", "K915393", "K853535", "K821749", "K971390", "K853720", "K821665", "K940616", "K851829", "K914758" ], "device_name": "Table, Operating-Room, Electrical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1", "registration_number": [ "", "1825014", "2247992", "3023449169", "3007123908", "3037012186", "3015131225", "3010890274", "8010153", "3042970964", "3030558088", "1824206", "3043178571", "3042992004", "3003900596", "3007143268", "1066635", "9613910", "8021896", "3003749961", "3009715914", "3007417753", "3010594257", "1066427", "3008610343", "1412854", "3043177791", "3005607354", "3006975482", "9710385", "3009567010", "3014680784", "3005083075", "9611102", "3006142326", "3006897996", "2916714", "3008881803", "3007278668", "2031963", "3008388379", "1066270", "3021559257", "3027847726", "3042991836", "3010446656", "2182536", "3014342096", "9680242", "3021839632", "3003574554", "1648279", "1836161", "3007238566", "3013836619", "3043654660", "3012165496", "3005843419", "3006697241", "3030516433", "3013774640", "3006063136", "1717548", "3010373494", "3003851947", "3013846070", "3015376465", "3030681105", "3020703842", "3014302716", "3010373263", "2020550", "9680168", "3010326005", "3016590299", "3010202439", "3011580044", "3015468226", "3011537487", "3003604053", "3015223105", "3011659880", "3011547624", "9611503", "3034669683", "3009610508", "8030607", "3011647337", "3031582440", "9681454", "3030194752", "3025628903", "3003696170", "3017884063", "1043572", "3006223081", "3012708860", "3029970239", "3003898943", "3017181414", "3031700059", "3015286905", "3009129579", "3035678069", "3011574775", "9610617", "1643264", "3033433849", "3002532594", "1000122786", "3009212453", "3015515531", "9680579" ], "fei_number": [ "", "1825014", "3023449169", "3007123908", "3037012186", "3015131225", "3010890274", "3042970964", "3030558088", "1824206", "3043178571", "3042992004", "3003900596", "3007143268", "3003749961", "3009715914", "3007417753", "3010594257", "3008610343", "1412854", "3043177791", "3005607354", "3006975482", "3002808268", "3009567010", "3005083075", "3001168737", "3006142326", "3006897996", "1000295034", "1825560", "2916714", "3008881803", "3007278668", "3004574120", "3006125657", "3008388379", "3021559257", "3027847726", "3042991836", "3010446656", "2182536", "3014342096", "3003574554", "3007238566", "3013836619", "3043654660", "1000516389", "3012165496", "3005843419", "3006697241", "3030516433", "3013774640", "3006063136", "3002750084", "1717548", "3010373494", "3002808335", "3007475226", "3009504761", "3003851947", "3013846070", "3015376465", "3030681105", "3002808001", "3020703842", "3014302716", "3007513035", "1000208827", "3003184737", "3010373263", "2020550", "3010326005", "3016590299", "3011580044", "3003138129", "3015468226", "1000125341", "3011537487", "3003604053", "3015223105", "3011659880", "3011547624", "3034669683", "3009610508", "3011647337", "3002572935", "3031582440", "3030194752", "3025628903", "3003696170", "3017884063", "1043572", "3000957797", "3006223081", "3012708860", "3029970239", "3003898943", "3017181414", "3031700059", "3015286905", "1000203464", "3009129579", "3035678069", "3011574775", "3002975342", "1643264", "3033433849", "3002532594", "1000122786", "3009212453", "3015515531", "3006509795" ] } } ] }