{ "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": "177032", "product_res_number": "Z-0496-2020", "event_date_initiated": "2019-10-04", "event_date_created": "2019-11-19", "recall_status": "Open, Classified", "res_event_number": "84032", "product_code": "FZP", "k_numbers": [ "K152084" ], "product_description": "WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML \n\nAutomatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips", "code_info": 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"firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "additional_info_contact": "Customer Service\n866-396-2111", "reason_for_recall": "Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).", "root_cause_description": "Under Investigation by firm", "action": "The firm notified their consignees by letter on 10/04/2019. The letter explained the issue and requested the user discontinue use and contact the company for instructions for their return. Distributors were directed to notify their customers and collect the affected product for return to Teleflex Medical.", "product_quantity": "34491 devices", "distribution_pattern": "Worldwide distribution, including US nationwide (including Puerto Rico).", "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", 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"1614993", "3016245399", "2246552", "3006082230", "3020965506", "3024021261", "2022435", "3001650400", "3013176080", "3035366890", "2916714", "3004060107", "3009380063", "3002807555", "3015207155", "3016248634", "3014279513", "3010605922" ], "device_name": "Clip, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }