{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "126188", "product_res_number": "Z-1329-2014", "event_date_initiated": "2014-02-19", "event_date_posted": "2014-04-03", "recall_status": "Open, Classified", "res_event_number": "67736", "product_code": "FTM", "k_numbers": [ "K060713" ], "product_description": "Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. \n\nEthicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.", "code_info": "Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159", "firm_fei_number": "2210968", "recalling_firm": "Ethicon, Inc.", "address_1": "US Highway 22 West", "city": "Somerville", "state": "NJ", "postal_code": "08876", "additional_info_contact": "908-218-0707", "reason_for_recall": "The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.", "root_cause_description": "Under Investigation by firm", "action": "Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. \n\nCustomers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or ethicon5798@stericycle.com. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.", "product_quantity": "223 units", "distribution_pattern": "US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.", "openfda": { "k_number": [ "K141721", "K110402", "K160181", "K214070", "K001738", "K040835", "K192616", "K851086", "K182259", "K051048", "K081882", "K134033", "K070738", "K130547", "K113460", "K082687", "K820619", "K120605", "K060984", "K091499", "K183398", "K831727", "K170016", "K052322", "K020049", "K896946", "K071986", "K063556", "K132025", "K133306", "K062320", "K053562", "K173242", "K830889", "K973379", "K101587", "K040756", "K060829", "K262406", "K043259", "K142326", "K992537", "K021160", "K030782", "K011027", "K203600", "K040119", "K940205", "K991567", "K161221", "K201313", "K063178", "K071065", "K160869", "K961810", "K831726", "K060989", "K140306", "K040621", "K831725", "K034039", "K152206", "K112786", "K112423", "K162934", "K071807", "K971048", "K150712", "K922308", "K081538", "K250598", "K852011", "K070405", "K083039", "K091142", "K110581", "K983162", "K061030", "K041669", "K192452", "K203496", "K201000", "K162554", "K120019", "K991296", "K170763", "K070560", "K162965", "K982330", "K031332", "K923657", "K111584", "K043388", "K021056", "K142070", "K040364", "K050246", "K062696", "K073219", "K182493", "K073391", "K162570", "K021107", "K090778", "K062915", "K200311", "K844228", "K141084", "K083898", "K123356", "K171817", "K844225", "K041140", "K020455", "K153633", "K111436", "K094061", "K150668", "K233991", "K223052", "K031969", "K213125", "K062558", "K090880", "K011025", "K082682", "K103787", "K081272", "K172937", "K023237", "K192615", "K062729", "K083823", "K033985", "K182255", "K053655", "K080452", "K122048", "K051879", "K141053", "K241126", "K213163", "K915774", "K243595", "K162461", "K040868", "K980431", "K142887", "K082176", "K162388", "K831723", "K042809", "K140501", "K183472", "K963175", "K071016", "K061892", "K021105", "K050337", "K041923", "K162752", "K961811", "K013625", "K894580" ], "registration_number": [ "3009882464", "3009039068", "2245304", "1221816", "2023811", "3010400367", "9615742", "3027383505", "3012669262", "1835959", "3005497913", "2530154", "3009493875", "3010894343", "3010178296", "1319660", "3016003911", "1111225", "3015413883", "3002719998", "1048735", "3009417901", "1820334", "9614442", "3027448274", "3045042524", "3036710971", "2183620", "3005636544", "3014461810", "8010177", "2249852", "3004681519", "3002924436", "3013820501", "3010155661", "3002807561", "3012358417", "1000393132", "3013666218", "8043792", "3005619880", "1550222", "3014003617", "3003604053", "3000931034", "3005920706", "1450662", "3003418325", "9617465", "3007321028", "9680579", "2183744", "3010513348", "2246552", "2124215", "1220477", "3003936139", "1416980", "3012547639", "3015543569", "1526534", "1018470", "2024024", "1647098", "3008812560", "3006017180", "3008868758", "2244478", "3000215346", "3004464325", "2132242", "3013307971", "3016429246", "1649390", "1818910", "2030598", "3015531529", "1047843", "1121308", "3004170064", "3012102437", "3009504230", "3010600625", "3003300673", "1018233", "3016823837", "1213643", "3012448339", "1220948", "3018094310" ], "fei_number": [ "3009882464", "3009039068", "2245304", "2023811", "3010400367", "3027383505", "3000718467", "3012669262", "3005497913", "1000203464", "3009493875", "3010894343", "3016003911", "1111225", "3015413883", "3002719998", "1048735", "3003769549", "3009417901", "1820334", "3027448274", "1000136478", "3045042524", "3002808269", "3036710971", "2183620", "3005636544", "3014461810", "3002340648", "3002924436", "3013820501", "3010155661", "3002807561", "3012358417", "1000393132", "3013666218", "3005619880", "1550222", "3014003617", "3003604053", "3000931034", "3005920706", "1450662", "3003418325", "3007321028", "1000143837", "3003870583", "2183744", "3010513348", "2246552", "2124215", "1220477", "3003936139", "1416980", "3012547639", "1000148471", "3003110073", "3015543569", "1526534", "1018470", "2024024", "3008812560", "3006017180", "3008868758", "1000518731", "3000215346", "3003521774", "3004464325", "1000136269", "3013307971", "3002821504", "3016429246", "1818910", "1000306051", "3015531529", "1047843", "1000307073", "1121308", "3004170064", "3012102437", "3009504230", "3008817245", "3010600625", "3003300673", "1018233", "3016823837", "3000303710", "1213643", "3012448339", "1220948", "3018094310" ], "device_name": "Mesh, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ] }