{ "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": 1 } }, "results": [ { "cfres_id": "129970", "product_res_number": "Z-0040-2015", "event_date_initiated": "2014-07-18", "event_date_posted": "2014-10-08", "recall_status": "Terminated", "event_date_terminated": "2015-08-05", "res_event_number": "69146", "product_code": "OMP", "k_numbers": [ "K082426", "K102001" ], "product_description": "RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier\n\nProduct Usage:\nRENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).", "code_info": "Item 66800423 Lot # M400058 & Item 66801066 Lot # M400124", "firm_fei_number": "3006760724", "recalling_firm": "Smith & Nephew, Inc.", "address_1": "970 Lake Carillon Dr", "address_2": "Ste 110", "city": "Saint Petersburg", "state": "FL", "postal_code": "33716-1130", "additional_info_contact": "727-392-1261", "reason_for_recall": "RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.", "root_cause_description": "Device Design", "action": "Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.", "product_quantity": "77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of\nCanada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.", "openfda": { "k_number": [ "K083357", "K113236", "K150006", "K090130", "K121817", "K151872", "K191101", "K061367", "K142385", "K171499", "K152741", "K122132", "K201571", "K231646", "K161418", "K070904", "K180618", "K221891", "K261291", "K090638", "K161432", "K190119", "K231939", "K221223", "K180205", "K151326", "K132004", "K141437", "K142626", "K080275", "K143004", "K142956", "K232379", "K092992", "K200223", "K111280", "K132225", "K142916", "K113291", "K090258", "K021500", "K161128", "K063740", "K163387", 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