{ "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": 2 } }, "results": [ { "cfres_id": "194589", "product_res_number": "Z-1481-2022", "event_date_initiated": "2020-04-01", "event_date_created": "2022-07-29", "recall_status": "Completed", "res_event_number": "90493", "product_code": "KOA", "product_description": "PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10", "code_info": "UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.", "firm_fei_number": "2916714", "recalling_firm": "Aesculap Implant Systems LLC", "address_1": "3773 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8217", "additional_info_contact": "800-258-1946", "reason_for_recall": "Endoscopic graspers may become separated at the weld from handle to the shaft of the device.", "root_cause_description": "Process change control", "action": "A notification letter was issued April 30, 2020 sent USPS Certified mail . The notification identifies the products as Catalog Item # 8360-10 PRESTIGE ATRA GRASPER DBL-ACT 5MM and 8361-10 PRESTIGE RETR GRASPER DBL-ACT 5MM. Customers were to evaluate inventory with a \"tug test\" and submit the notification acknowledgment form. Should a device fail the tug test, customers were to file a complaint using Aesculap's Online Customer Complaint Submission Form and return a the product. The products have since been discontinued.", "product_quantity": "3392", "distribution_pattern": "United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.", "openfda": { "k_number": [ "K810915", "K813504", "K851112", "K921304", "K834191", "K772134", "K760716", "K852726", "K921546", "K851111", "K760715", "K841003", "K820015", "K811973", "K891352", "K922971", "K811223", "K832677", "K801273", "K851113", "K182664", "K811693", "K830786", "K852014", "K931181", "K822401", "K922192", "K950267", "K841387", "K864963", "K800441", "K834171", "K810533", "K863273", "K761229", "K921228", "K890218", "K852725", "K760717", "K802983", "K932465", "K851162", "K896058", "K834192" ], "device_name": "Surgical Instruments, G-U, Manual (And Accessories)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4730", "device_class": "1", "registration_number": [ "3005440795", "8021955", "1061124", "1820334", "3009888344", "3005012805", "9610773", "3006696607", "8010370", "2020550", "3004550973", "2434839", "2124215", "3005528784", "3002647932", "3022862651", "8043746", "3013247477", "1925025", "9616088", "3004638532", "3007695959", "3042991836", "8030607", "3011545155", "1018233", "1058584", "3011050570", "3002834291", "3010202439", "3007329020", "3011137372", "1422507", "3013298431", "1423537", "3015972835", "3016447772", "2431166", "3013317267", "3030516433", "3008720584", "3012226300", "1421879", "3009217531", "5906", "1825146", "3003965134", "2916714", "3007773213", "1000379913", "8010269", "3010699884", "3007648354", "9611590", "3027588012", "2084346", "1412854", "3005099803", "3006082230", "3008770252", "3033536312", "3014211785", "9613910", "8040278", "9681129", "1643817", "3003790304", "3005067367", "3005273623", "3007137643", "1526534", "1423662", "3009039068", "9680718", "9680357", "1421101", "3005049530", "8043769", "3006973666", "3015895045", "1836161", "3010041511", "3006410968", "1928237", "9611112", "9610612", "3006554912", "8010422", "3002769835", "3013960851", "1627186", "3008338766", "2030624", "2531475", "3007123908", "1219930", "3010155661", "1417592", "3018094310", "1651252", "3008902714", "3004111573", "9680515", "3004215117", "8010733", "3029082594", "3022505514", "3012267976", "3005698350", "1519132", "3013987875", "2133687", "1216677", "2125050", "2647580" ], "fei_number": [ "3005440795", "3000206619", "3002750084", "1000124817", "1820334", "3009888344", "3005012805", "3006696607", "1000179044", "3007573441", "2020550", "3004550973", "2434839", "2124215", "3005528784", "3002647932", "3022862651", "3013247477", "3007475226", "3004638532", "3007695959", "3042991836", "3001236905", "3008238512", "3011545155", "1018233", "3011050570", "3002834291", "6082", "1000512168", "3007329020", "1000118065", "3006509795", "3013298431", "1000159990", "3015972835", "3008782585", "3016447772", "3013317267", "3030516433", "3008720584", "3005969827", "3012226300", "3009217531", "5906", "1825146", "3003965134", "2916714", "3007773213", "1000379913", "3010699884", "3007648354", "3002770040", "3027588012", "1412854", "3005099803", "3006082230", "3008770252", "3033536312", "3014211785", "2523865", "3000206435", "1643817", "3005747797", "3003790304", "3000280067", "3001417518", "1000219637", "3005273623", "1000237915", "3007137643", "1526534", "3004829691", "3009039068", "1421101", "3005049530", "3006973666", "3015895045", "3004595684", "3010041511", "3006410968", "1928237", "3002806976", "3006554912", "3002769835", "3013960851", "1627186", "3008338766", "3007123908", "1219930", "3010155661", "4417", "1417592", "3018094310", "3001642379", "3000215273", "3008902714", "3004574120", "3004111573", "3004215117", "3029082594", "3546", "1000115048", "3004216008", "3022505514", "3012267976", "3005698350", "1519132", "3013987875", "3002806315", "1216677", "2125050", "3002807798", "2647580", "3002902735" ] } } ] }