{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "219199", "product_res_number": "Z-1816-2026", "event_date_initiated": "2026-03-19", "event_date_posted": "2026-04-15", "recall_status": "Open, Classified", "res_event_number": "98607", "product_code": "KGN", "k_numbers": [ "K152721" ], "product_description": "Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.", "code_info": "Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011.", "firm_fei_number": "3003418325", "recalling_firm": "Integra LifeSciences Corp. (NeuroSciences)", "address_1": "1100 Campus Rd", "city": "Princeton", "state": "NJ", "postal_code": "08540-6650", "additional_info_contact": "Sajeel Afzal\n1-640-2619909", "reason_for_recall": "Increased rate of out-of-specification endotoxin results.", "root_cause_description": "Under Investigation by firm", "action": "Integra LifeSciences notified consignees on about 03/19/2026 via letter. Consignees were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Consignees were also instructed to forward to all affected personnel who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas.\n\nDistributors were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Distributors were also instructed to check customer traceability records and notify them if they have any shipments with affected units. They requested to modify the acknowledgement form to provide to customers, collect completed response forms and provide those numbers in the distributor reply form.\n\nIntegra LifeSciences sent a second notification letter on about 03/20/2026, which updated the lot numbers affected. Consignees were asked to disregard the previous letter and replace it with the updated one. Directions for consignees and distributors did not change.", "product_quantity": "148 units", "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.", "openfda": { "k_number": [ "K950281", "K172399", "K172593", "K014129", "K003134", "K213716", "K142712", "K253140", "K083440", "K950032", "K140456", "K081635", "K913023", "K103648", "K134037", "K131286", "K201577", "K253339", "K040558", "K233378", "K022127", "K133290", "K231325", "K232204", "K232796", "K210024", "K250864", "K211902", "K963228", "K061474", "K212579", "K260532", "K213341", "K100574", "K162759", "K910944", "K973170", "K200502", "K071425", "K253521", "K935189", "K790496", "K180776", "K213231", "K242100", "K213498", "K240753", "K955506", "K241724", "K002443", "K250329", "K970266", "K070269", "K141738", "K020732", "K241080", "K200413", "K254034", "K173005", "K012990", "K882590", "K030774", "K100927", "K210580", "K241706", "K251845", "K123961", "K253204", "K231937", "K193552", "K132343", "K901369", "K110318", "K260218", "K182010", "K021637", "K213573", "K191992", "K210128", "K082869", "K140367", "K221520", "K122502", "K021792", "K213607", "K990086", "K112191", "K252673", "K000054", "K140820", "K212766", "K092805", "K893647", "K242146", "K982597", "K182838", "K213092", "K241904", "K260669", "K140510", "K102946", "K230980", "K113866", "K210949", "K090894", "K914024", "K153754", "K061494", "K925545", "K040403", "K993948", "K223126", "K160136", "K072113", "K220317", "K090812", "K061746", "K152600", "K060888", "K122325", "K252001", "K220498", "K061407", "K022854", "K843788", "K090823", "K050177", "K120339", "K162348", "K171231", "K143426", "K231152", "K190528", "K251323", "K000487", "K253974", "K060456", "K061711", "K092096", "K080868", "K242985", "K250397", "K112399", "K192346", "K260711", "K260596", "K143124", "K181330", "K090954", "K896110", "K192386", "K172010", "K112409", "K120250", "K192725", "K994339", "K040314", "K984388", "K153690", "K171842", "K092926", "K011026", "K113104", "K223257", "K112888", "K261224", "K091338", "K990964", "K110388", "K240277", "K232758", "K082103", "K040211", "K241866", "K171645", "K122115", "K081724", "K081782", "K101546", "K213598", "K123756", "K112580", "K080010", "K152721", "K030921", "K243071", "K242828", "K231614", "K152033", "K173223", "K023778" ], "registration_number": [ "3002907620", "3004431266", "1060680", "3015058854", "3007321028", "3010600625", "2030598", "1225991", "3008770963", "1648579", "2530154", "2135152", "3015542130", "3014146451", "3018348", "3016429246", "3007594734", "3043861816", "3042617688", "3039169663", "3015282703", "1121308", "1047843", "2032542", "3014211822", "3006802076", "3015525200", "3013820501", "3017399129", "2431866", "1929833", "3005433617", "2024024", "3007124979", "3012448339", "3031600472", "3003768919", "3007738736", "3010824458", "3012494290", "1835959", "3012535730", "3015946784", "3011191255", "3005920706", "3013517171", "1720734", "3015442987", "1646434", "2029275", "3003418325", "3039592366", "8043396", "3036710971", "1650372", "3010894343", "3042750477", "3008374791", "1649518", "3017107376", "3016904853", "1058584", "3009882464", "3015238043", "3019356409", "3002636527", "3032911850", "1319660", "1000393132", "3004799623", "3007735241", "3030067857", "2530957", "3015309358", "3004170064", "3042708438", "3013012623", "3011649314", "3017660750", "3027517726", "3003636207", "3011276344", "3015980493", "8043484", "3014078231", "3046781339", "3025316685", "9614442", "3017297225", "3027419979", "2249852", "3007663067", "3031238659", "3008102042", "8043792", "3009109670", "9680091", "3034456223", "2245437", "3010097129", "3014820861", "3004117927", "2245539", "1645368", "1066741", "3003300673", "3010668881", "3004713654", "3017391151", "2435946", "3021784063", "9680579", "3012973796", "3009504230", "1043214", "3004189237", "3027448274", "3009988302", "3012940386", "2245304", "3012823434", "1720929", "3004146122", "3009317711", "3010187826", "3009973323", "3017633586", "1417592", "3014498807", "3009656988", "1064858", "3031743608", "1220477", "3012102437", "3016615875", "3010155661", "3014982332", "1450662", "1221816", "1531062" ], "fei_number": [ "3002907620", "3004431266", "3015058854", "3007321028", "3010600625", "1000117860", "3008770963", "3001236277", "3014146451", "3015542130", "3018348", "3016429246", "3007594734", "3043861816", "1000518731", "3042617688", "3039169663", "3015282703", "1121308", "1047843", "1000148471", "3006802076", "3002924544", "3015525200", "3013820501", "1000138377", "3017399129", "2431866", "1929833", "3005433617", "3003005156", "2024024", "1000307073", "3007124979", "3012448339", "3000303710", "3031600472", "3003768919", "3007738736", "3010824458", "3012494290", "3012535730", "3015946784", "3011191255", "3005920706", "3009710316", "3013517171", "1720734", "3015442987", "3003646540", "3003418325", "3039592366", "3036710971", "3010894343", "3042750477", "1000136478", "3008374791", "3017107376", "3016904853", "3009882464", "3015238043", "3019356409", "1000219637", "1000137528", "3002636527", "3032911850", "1000393132", "3004799623", "3007735241", "1000208624", "3030067857", "3000205837", "3015309358", "3004170064", "3013012623", "3011649314", "3017660750", "3027517726", "3003636207", "3011276344", "3015980493", "3014078231", "3046781339", "3025316685", "3017297225", "3027419979", "3002808194", "3007663067", "3002808269", "1450662", "3031238659", "3009109670", "3034456223", "3005461046", "2245437", "3010097129", "3002340648", "3014820861", "2245539", "3004117927", "3003300673", "1000306431", "3010668881", "3004713654", "3008397795", "3017391151", "3021784063", "3002806830", "3002516348", "3002768455", "3012973796", "3009504230", "1043214", "3014298539", "3004189237", "3027448274", "3009988302", "3012940386", "2245304", "3012823434", "3008817245", "1720929", "3004146122", "3009317711", "3010187826", "3009973323", "3017633586", "1417592", "3014498807", "3009656988", "3002253367", "3031743608", "1220477", "3012102437", "3016615875", "3010155661", "3014982332", "1000203464", "3008162665", "1000522686" ], "device_name": "Wound Dressing With Animal-Derived Material(S)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "U" } } ] }