{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188469", "product_res_number": "Z-2326-2021", "event_date_initiated": "2021-06-03", "event_date_created": "2021-08-19", "recall_status": "Terminated", "event_date_terminated": "2022-09-14", "res_event_number": "88349", "product_code": "GDW", "k_numbers": [ "K202665" ], "product_description": "ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.\nProduct Code: PSEE60A", "code_info": "Lot U94V47\n\nExp Date: July 31, 2023\n\nGTIN: 10705036014607", "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": "SAME\n513-337-7000", "reason_for_recall": "Mislabeled: Labeled on the package as 60mm contains 45mm devices", "root_cause_description": "Packaging change control", "action": "Ethicon notified US consignees by Urgent Medical Device removal letter on 6/3/21 via Fed-Ex second day. Ethicon Johnson & Johnson Affiliates in impacted countries will notify their customers and health authorities per their local regulations and procedures.\nLetter states reason for recall, health risk and action to take:\n1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s).\n2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.\n3. If any product subject to this action has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating.\n4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and email it to Ethicon at ra-ethus-fa-ss@its.jnj.com within three (3) business days. To request a copy of the BRF that may be completed and signed electronically, please email ra-ethus-fa-ss@its.jnj.com. Please return the BRF even if you do not have product subject to this recall.\n5. Follow instructions in the letter and immediately return any inventory of ECHELON FLEX\" Powered Plus Stapler, Product Code PSEE60A, Lot U94V47. We request that product subject to this recall be returned no later than September 10, 2021 to Ethicon. Any non-affected product and any product returned after the date specified will not receive replacement.\n6. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Ethicon. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.\nIf you have additional questions regarding this voluntary medical device recall or require any assistance with returning product, please contact the Ethicon Res", "product_quantity": "763 eaches", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of MD, WA and the countries of Belgium, China, Denmark, Estonia, France, Germany, Italy, Japan, Korea, \nLatvia, Lithuania, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Switzerland, \nUnited Kingdom.", "openfda": { "k_number": [ "K243276", "K051301", "K012362", "K843034", "K120258", "K211458", "K191287", "K123109", "K160900", "K040024", "K202665", "K040109", "K192720", "K080898", "K161757", "K150026", "K152618", "K101961", "K091322", "K170348", "K211197", "K200420", "K210909", "K241630", "K102291", "K171561", "K915693", "K130653", "K102632", "K822345", 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"3015336263", "3014295858", "1450662", "1000136269" ], "device_name": "Staple, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4750", "device_class": "2" } } ] }