{ "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": "176698", "product_res_number": "Z-0201-2020", "event_date_initiated": "2019-10-03", "event_date_posted": "2019-10-29", "recall_status": "Terminated", "event_date_terminated": "2021-06-03", "res_event_number": "83897", "product_code": "GDW", "k_numbers": [ "K160521" ], "product_description": "ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A", "code_info": "Lot: T93Z9Y, T9411A", "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": "513-337-7000", "reason_for_recall": "The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.", "root_cause_description": "Nonconforming Material/Component", "action": "Urgent Medical Device Recall (Removal) letters were sent to customers beginning 10/3/19. The letters instruct customers to do the following:\n\nACTION REQUIRED:\n1. Examine your inventory immediately to determine if you have product subject to this recall on\nhand and quarantine such product(s).\n2. Remove the product subject to this voluntary recall and communicate the issue to relevant\noperating room or materials management personnel, or anyone else in your facility who needs\nto be informed.\n3. If any product subject to this recall has been forwarded to another facility, contact that facility to\narrange 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\nfax or email it to Stericycle at 1-866-300-3432 or ethicon7148@stericycle.com within three (3)\nbusiness days. Please return the BRF even if you do not have product subject to this\nrecall.\n5. Keep this notice visibly posted for awareness until all product subject to this recall has been\nreturned to Stericycle. While processing your returns, please maintain a copy of this notice with\nthe product subject to this recall and keep a copy for your records.\n6. Customers are required to return unused impacted ECHELON FLEX ENDOPATH 60mm\nStaplers subject to this recall that are in their inventory immediately. To receive replacement\nproduct, customers must return product subject to this recall by December 31, 2019. Any nonaffected\nproduct and any product returned after the date specified will not be replaced.\n7. To return product subject to this recall, photocopy the completed BRF, place it in the box with\nthe product, and affix the pre-paid authorized shipping label included with the recall notification\nletter. Ethicon will pay for the shipping charges only if the authorized label is used. Extra\nshipping labels may be obtained by calling Stericycle at 1-866-918-8756. Your account n", "product_quantity": "255 units", "distribution_pattern": "Worldwide distribution. US Nationwide. 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