{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205444", "product_res_number": "Z-0866-2024", "event_date_initiated": "2023-12-29", "event_date_posted": "2024-01-31", "recall_status": "Open, Classified", "res_event_number": "93793", "product_code": "HCF", "product_description": "MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4\", (220 mm), \"TC JACOBSON NDL HLD STR JAW 220MM\";", "code_info": "UDI-DI 4046955075546\n\nFirm did not identify affected lots or expiration date.\n\nAffected product was distributed between November 23, 2022 and October 13, 2023.", "firm_fei_number": "2916714", "recalling_firm": "Aesculap Inc", "address_1": "3773 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8217", "additional_info_contact": "Quality Assurance\n833-425-1464", "reason_for_recall": "Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.", "root_cause_description": "Nonconforming Material/Component", "action": "On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters.\n\nCustomers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.", "product_quantity": "53", "distribution_pattern": "US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.", "openfda": { "k_number": [ "K931379", "K150882", "K841617", "K790577", "K851452" ], "registration_number": [ "9612278", "5906", "3005528784", "3005067367", "1417592", "3007773213", "3003418325", "9616250", "3011024991", "9610612", "3013247477", "1047843", "3003807268", "8040233", "1720747", "3015976667", "9615005", "3008114965", "3010178296", "3010237768", "3008254127", "1058726", "9680242", "3013756169", "3004215117", "3010383847", "9611112", "3007137643", "3011547624", "3034669683", "3011706110", "2080222", "9680837", "3009513193", "3008936260", "3012185136", "2084346", "3008843439", "2011171", "2424366", "3012267976", "3011600579", "3007648354", "3009255580", "3018094310", "2031768", "3030516433", "3010470577", "3005440795", "1211566", "1056350", "9710524", "3016096142", "9611102", "3011499367", "1319660", "3008812251", "1926681", "3004598675", "9681572", "9612074", "3006154292", "9610773", "3004608878", "1220477", "3010041511", "1450662", "3023657851", "3015209038", "3008812560", "3021519357", "8010099", "3043355002", "1421101", "3007589150", "1219518", "3034543751", "8010518", "1219930", "8010877", "3007544634", "3030839824", "9611278", "8010547", "3010687973", "1221934", "3009889060", "3020954746", "8043746", "1320468", "1422634", "3032391", "1835444", "2031917", "3032747418", "8043548", "2126670", "1043214", "3009956343", "1836161", "3015895045", "1721676", "3004464325", "3003597504", "9680718", "3007597038", "3014840003", "3003431869", "3005049530", "3008770252", "2085947", "3004530184", "3031231776", "1424478", "1923569", "1412854", "3003675041", "3012415195", "3013658769", "1820334", "3004001706", "3010437008", "3003761012", "8030607", "3035708926", "8044098", "3010131578", "3016994953", "2245304", "1055236", "8040278", "3009495876", "9611283", "3008280196", "1421879", "3012995405", "3041277555", "2246552", "3008797953", "3011452218", "9615765", "9681702", "8010372", "8044057", "1646747", "3027556548", "3001620590", "3010462278", "3012507533", "3009142291", "3033536312", "2916714", "3006591312", "3030446844", "8020712", "1054241", "3043620689", "3011137372", "2320762", "2529846", "2953359", "1218017", "2528981", "2431166", "3016248634", "3014615697" ], "fei_number": [ "1000115048", "3005747797", "5906", "3005528784", "3003263857", "1417592", "3007773213", "3003418325", "3003772581", "3011024991", "3003040625", "3002808293", "3013247477", "1047843", "3003807268", "3004028763", "1720747", "1000136191", "1000514656", "3015976667", "3004595684", "3008114965", "1000168975", "3002806315", "3010237768", "3008254127", "3007137643", "3013756169", "3004215117", "3010383847", "3942", "3011547624", "3002929183", "3034669683", "3011706110", "3000206455", "3004216008", "3003749234", "2080222", "3000280067", "3009513193", "3008936260", "3012185136", "3008843439", "2011171", "2424366", "3012267976", "3011600579", "2523865", "3002750084", "3007648354", "3009255580", "3018094310", "3030516433", "3003110073", "3010470577", "3005440795", "1211566", "3006509795", "3003249645", "1000124817", "3016096142", "3008782585", "3011499367", "3003499455", "1926681", "3004598675", "3000215205", "3006154292", "3001286223", "3003944071", "3004608878", "3002807798", "1220477", "3010041511", "1450662", "3023657851", "3015209038", "3008812560", "3021519357", "3008237817", "3043355002", "3002902165", "1421101", "1000136478", "3007589150", "1219518", "3034543751", "1219930", "3546", "3007544634", "3030839824", "3002690289", "3010687973", "3002808264", "1221934", "3009889060", "3020954746", "3002806862", "3003445992", "4381", "3032747418", "2126670", "1043214", "1000112968", "3009956343", "3015895045", "3000204191", "3002807072", "1721676", "3004464325", "3003597504", "5870", "3014840003", "3003431869", "3005049530", "3008770252", "3004530184", "3031231776", "1923569", "1412854", "3003675041", "3012415195", "3013658769", "1820334", "3004001706", "3010437008", "3003761012", "3035708926", "3005276402", "3010131578", "3016994953", "2245304", "1000307733", "1000112877", "3007290840", "1000347621", "1000140363", "3009495876", "3008280196", "1000160162", "3012995405", "3041277555", "2246552", "3008797953", "3002299608", "3011452218", "3002806816", "3027556548", "3001620590", "3010462278", "3012507533", "3009142291", "3033536312", "2916714", "3009504761", "3006591312", "3030446844", "3043620689", "1218017", "2528981", "3002808001", "3003756816", "3016248634", "3014615697", "3000717687" ], "device_name": "Instrument, Ligature Passing And Knot Tying", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }