{ "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": "177940", "product_res_number": "Z-0656-2020", "event_date_initiated": "2019-11-07", "event_date_created": "2019-12-06", "recall_status": "Terminated", "event_date_terminated": "2021-04-23", "res_event_number": "84280", "product_code": "FZP", "k_numbers": [ "K110699" ], "product_description": "Ligamax 5 mm Endoscopic Multiple Clip Applier", "code_info": "Product Code: 11EL5ML Lot Numbers: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F, T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99 T94H1N, T94H78", "firm_fei_number": "1527736", "recalling_firm": "Ethicon Endo-Surgery Inc", "address_1": "4545 Creek Rd", "city": "Blue Ash", "state": "OH", "postal_code": "45242-2803", "additional_info_contact": "Stephanie Matthews\n513-337-3521", "reason_for_recall": "A potential exists that certain LIGAMAX devices within\nthe impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.", "root_cause_description": "Under Investigation by firm", "action": "On November 7, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating:\nURGENT: MEDICAL DEVICE RECALL (REMOVAL)\nLIGAMAX 5mm Endoscopic Multiple Clip Applier\nProduct Codes: EL5ML\n(Multiple Lot Numbers)\n\nDear Valued Customer\nEthicon has initiated a voluntary medical device recall (removal) of specific lots of LIGAMAX 5mm Endoscopic Multiple Clip Applier. Ethicon identified that a potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility. In the event that the sterility barrier has been breached, there is a chance that a pathogen may be introduced and if unrecognized or untreated may cause life threatening infection. As the population at risk is most likely to receive prophylactic antibiotics the probability of harm is extremely rare. We have identified the root cause and have implemented corrective actions to address the issue and prevent reoccurrence. As of the date of this communication, no adverse events or complaints have been reported for this issue.\n\nOur records indicate that you may have ordered or received product subject to this recall. PLEASE DISTRIBUTE THIS INFORMATION TO ALL STAFF WITHIN YOUR FACILITY WHO USE LIGAMAX 5mm ENDOSCOPIC MULTIPLE CLIP APPLIER. The dates of distribution for affected products were from July 31, 2019 thru October 4, 2019.\n\nEFFECTIVE IMMEDIATELY DO NOT USE OR DISTRIBUTE THE FOLLOWING PRODUCT CODE/ LOT:\nProduct Name: LIGAMAX\nProduct Code: EL5ML\nProduct Lots: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F\nT94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A, T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99, T94H1N\nT94H78\nDescription/Size: 5mm Endoscopic Multiple Clip Applier\n\nNote: This recall is specific to lots described.\n\nHealth care practitioners who have treated pat", "product_quantity": "48,428", "distribution_pattern": "US: Nationwide\n\nInternational: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA\nPHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK", "openfda": { "k_number": [ "K032238", "K150840", "K021407", "K993424", "K841549", "K053252", "K040821", "K030311", "K071406", "K873309", "K232313", "K933887", "K143598", "K081031", "K091060", "K050344", "K151943", "K964470", "K982944", "K132658", "K020879", "K142777", "K030926", "K073123", "K033024", "K800079", "K851251", "K250643", "K173031", "K131107", "K140932", "K841548", "K032217", "K121194", "K220006", "K962043", "K020470", "K181488", "K091017", "K013264", "K032980", "K242541", "K152081", "K862404", "K945231", "K962016", "K200166", "K011402", "K230966", "K934087", "K964109", "K230480", "K915151", "K021808", "K142869", "K110699", "K864102", "K221495", "K900122", "K080753", "K950540", "K091987", "K011236", "K062057", "K902108", "K111930", "K012317", "K953908", "K771112", "K843589", "K820999", "K061288", "K944552", "K834267", "K971201", "K122276", "K150259", "K853650", "K072525", "K842382", "K905587", "K801124", 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"K953258", "K232970", "K063644", "K180650" ], "registration_number": [ "1020279", "3015453963", "3007829657", "2210968", "3045042524", "2029275", "3011430871", "1416980", "3026616094", "1417592", "3015183635", "3014479313", "3035387162", "9610612", "3008989837", "1047843", "2027111", "3015542154", "3009763019", "1825034", "3016678045", "3013184361", "3017196117", "3005160949", "3004215117", "3010383847", "3005636544", "2647580", "3011706110", "3008843439", "9612501", "3021194552", "3018094310", "1220948", "3003898360", "3011989923", "3004111573", "3004365956", "3017102971", "3014461810", "3007185216", "3005075853", "1527736", "9616088", "3014620201", "2024024", "3009609358", "1018470", "3010041511", "3008492462", "3008992312", "3017636737", "1219930", "2132556", "3030733800", "3015185328", "3009051888", "3008729892", "3012494290", "3017210488", "3008236846", "3038503932", "3021632375", "1422634", "3007205024", "3002907620", "3011683674", "1423537", "1043214", "1836161", "3015895045", 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"3016248634", "3014279513", "3010605922" ], "device_name": "Clip, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }