{ "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": 4 } }, "results": [ { "cfres_id": "191888", "product_res_number": "Z-0746-2022", "event_date_initiated": "2022-01-20", "event_date_created": "2022-03-10", "recall_status": "Open, Classified", "res_event_number": "89534", "product_code": "EBZ", "k_numbers": [ "K201173" ], "product_description": "PCA 4000 Curing Units, SKU number ACC-06-1000\n\nThe PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.", "code_info": "All units\nSKU number ACC-06-1000", "firm_fei_number": "3009261582", "recalling_firm": "Envisiontec US Llc", "address_1": "15162 S Commerce Dr", "city": "Dearborn", "state": "MI", "postal_code": "48120-1237", "additional_info_contact": "Miguel Gomez\n313-436-4300", "reason_for_recall": "The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.", "root_cause_description": "Unknown/Undetermined by firm", "action": "The firm, Evisiontec US LLC., sent \"URGENT: PRODUCT RECALL\" notification letters dated 1/20/22 to customers.\n\nACTION:\n1. Stop utilizing the PCA 4000 to print medical devices made from EnvisionTec dental resins.\n2. Please carry out a physical count and record this data on the Recall Response Form included with this letter.\n3. Submit the Recall Response Form by e-mail: envisiontec4279@sedgwick.com or fax to: 866-875-0545 even if you do not have the recalled product.\n4. Contact EnvisionTec customer service at envisiontec.com/support to arrange for the return and replacement of the recalled product.\n\nThis recall is being carried out only for the specific products identified above; no other\nproducts are involved in this recall. Notifications of this recall are being sent to all\naccounts to whom EnvisionToc shipped a recalled product. For customers that\nredistribute this product to other accounts, please notify your accounts. For questions\nabout the recall process please contact Sedgwick at 1-866-512-4073. For other\ninquiries regarding these products and to initiate your return, please contact\nEnvision Tac customer service at envisiontec.com/support (if you do not have access\nto the Internet, contact Sedgwick at the toll-free number above with your contact\ninformation and EnvisionTec customer service will promptly contact you to arrange\nyour return).\n\nA replacement curing unit of equal or greater value will be provided to customers; if\nreplacement is not available, a credit will be issued to customers at the price in effect\nat the time of purchase.", "product_quantity": "172 units", "distribution_pattern": "US Nationwide", "openfda": { "k_number": [ "K110582", "K912994", "K040614", "K220826", "K012341", "K163064", "K960351", "K003383", "K131042", "K110756", "K070373", "K180065", "K200809", "K000393", "K942199", "K020267", "K913980", "K020884", "K992236", "K770215", "K001719", "K013500", "K780898", "K163605", "K820693", "K011154", "K173157", "K880392", "K220471", "K854696", 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