{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216281", "product_res_number": "Z-0172-2026", "event_date_initiated": "2025-09-04", "event_date_posted": "2025-10-16", "recall_status": "Open, Classified", "res_event_number": "97659", "product_code": "LRO", "product_description": "Medical convenience kits \n\nItem number/ Product description\nAKGN82E\tGENERAL\nAMCB08Y\tCHEST BREAST PACK\nANBP10AC\tBASIC PACK - 205939\nANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953\nCFLA39G\tLAPAROTOMY PACK\nCIBL33I\tBASIC LAP PACK\nEVMN24E\tMINOR ESC\nEVST48E\tSTARTER\nFDTA11AA\tT & A PACK\nFHHY25P\tHYSTEROSCOPY PACK\nHGML99G\tMAJOR LAP PACK\nHGXR41H\tX-RAY PACK\nHISU54M\tSET-UP PACK\nIHAA19AP\tPK A A A\nIHMP89K\tMINOR PROCEDURE PACK\nIHPD14AM\tPK PEDIATRIC\nLKVG10O\tVAG DELIVERY\nLMAG20G\tVASCULAR PACK\nLMLE46AA\tEXTREMITY LOWER PK\nMIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)\nNUMB04H\tMAJOR BASIN SET 314666\nOWBS11U\tBASIN SET - 206021\nRCMS71B\tMIS SPECIALTY RCH\nSFMB55X\tMINOR BASIN - 208293\nSTBA09F\tBASIN SET \nTNBS21O\tBASIN SET 612833\nUDBH37AX\tBASIC HEART PACK - 206044\nUDMA50X\tMINOR ADULT - 206067\nUICR54W\tACS CRS PACK (PS055042)\nUIPC89D\tPROCUREMENT PACK\nUIPT13F\tPITCHER (PS 907953)\nUISB96AB\tSMALL BACK TABLE SETUP (PS 907419)", "code_info": "AKGN82E\nUDI-DI 191072229281\nLot 7352211\nBag serial number 47384448;\n\nAMCB08Y\nUDI-DI 191072185082\nLot 8069911\nBag serial number 68117042;\n\nANBP10AC\nUDI-DI 191072214300\nLot 8125811\nBag serial numbers\n17487164\n17488117;\n\nANIR77AM\nUDI-DI 191072236692\nLot 8394711\nBag serial numbers\n58588193\n58588194\n68563615\n68663621;\n\nCFLA39G\nUDI-DI 191072203496\nLot 8484911\nBag serial numbers\n68642706;\n\nCIBL33I\nUDI-DI 191072186409\nLot 8044011\nBag serial number N/A;\n\nEVMN24E\nUDI-DI 191072215093\nLot 8184711\nBag serial number\n68198257;\n\nEVST48E\nUDI-DI 191072224064\nLot 7366711\nBag serial number\n68194868;\n\nFDTA11AA\nUDI-DI 191072159236\nLot 8522811\nBag serial number\n47864258;\n\nFHHY25P\nUDI-DI 191072157256\nLot 8031711\nBag serial number\n68152897;\n\nHGML99G\nUDI-DI 191072212580\nLot 8316911\nBag serial number\n68244067;\n\nHGXR41H\nUDI-DI 191072212672\nLot 8285311\nBag serial number N/A;\n\nHISU54M\nUDI-DI 191072212399\nLot 7969611\nBag serial number\n17427513;\n\nIHAA19AP\nUDI-DI 191072224187\nLot 8035011\nBag serial number 68048038;\n\nIHMP89K\nUDI-DI 191072159960\nLot 8024811\nBag serial number 68154486;\n\nIHPD14AM\nUDI-DI 191072227232\nLot 8180911\nBag serial number 68200149;\n\nLKVG10O\nUDI-DI 191072158666\nLot 7957411\nBag serial number N/A;\n\nLMAG20G\nUDI-DI 191072158680\nLot 7964411\nBag serial number N/A;\n\nLMLE46AA\nUDI-DI 191072237880\nLot 8500811\nBag serial number 68642780;\n\nMIEN58A\nUDI-DI 191072231444\nLot 8118411\nBag serial number N/A;\n\nNUMB04H\nUDI-DI 191072202895\nLot 7993111\nBag serial number N/A;\n\nOWBS11U\nUDI-DI 191072214843\nLot 8069411\nBag serial numbers\n47507802\n47508002\n47508012;\n\nRCMS71B\nUDI-DI 191072226150\nLot 7950311\nBag serial number N/A;\n\nSFMB55X\nUDI-DI 191072217851\nLot 7971211\nBag serial number N/A;\n\nSFMB55Y\nUDI-DI 191072229991\nLot 8096711\nBag serial number N/A\nLot 8179711\nBag serial numbers \n17556181\n17557278;\n\nSTBA09F\nUDI-DI 191072208798\nLot 8079711\nBag serial number 17506128;\n\nTNBS21O\nUDI-DI 191072199775\nLot 8115211\nBag serial number N/A\nLot 8432911\nBag serial number N/A;\n\nUDBH37AX\nUDI-DI 191072238740\nLot 8454211\nBag serial number\n68703044;\n\nUDMA50X\nUDI-DI 191072172587\nLot 8084711\nBag serial number 17390548\nLot 8183611\nBag serial number 17554620;\n\nUICR54W\nUDI-DI 191072228932\nLot 8142811\nBag serial number N/A;\n\nUIPC89D\nUDI-DI 191072205742\nLot 7956111\nBag serial number N/A;\n\nUIPT13F\nUDI-DI 191072107121\nLot 8049111\nBag serial number 68047422;\n\nUISB96AB\nUDI-DI 191072205797\nLot 8147011\nBag serial number N/A\n\n* If \"N/A\" for bag serial number, then whole lot is affected", "firm_fei_number": "3007069947", "recalling_firm": "American Contract Systems Inc.", "address_1": "1601 Se Gateway Dr Ste 120 1601 Se Gateway Dr", "address_2": "Ste 120", "city": "Grimes", "state": "IA", "postal_code": "50111-5223", "additional_info_contact": "Marlene Jones\n470-280-4277", "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.", "root_cause_description": "Nonconforming Material/Component", "action": "Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.\n\nConsignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.", "product_quantity": "32,433 total", "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.", "openfda": { "k_number": [ "K212258", "K934028", "K951149", "K894685", "K871873", "K963721", "K883250", "K890098", "K932217", "K881083", "K945160", "K962826", "K933137", "K920292", "K965201", "K884093", "K873973", "K923600", "K936117", "K910368", "K854292", "K934428", "K971062", "K871459", "K953083", "K041080", "K931759", "K874760", "K971061", "K890729", "K880961", "K930700", "K905459", "K023276", "K902293", "K935686", "K964921", "K931673", "K913136", "K935483", "K951478", "K914036", "K941846", "K874439", "K893814", "K914037", "K890570", "K213481", "K914174", "K914935", "K950574", "K871437", "K902887", "K880942", "K932652", "K970187", "K882684", "K945481", "K970286", "K842648", "K030721", "K961863", "K925216", "K890658", "K926269", "K924468", "K935858", "K931760", "K902888", "K932220", "K901856", "K963715", "K903336", "K895202", "K872011", "K925016", "K931824", "K950295", "K920267", "K944044", "K932221", "K890726", "K872448", "K910365", "K935743", "K922648", "K934030", "K931844", "K934029", "K935741", "K931820", "K952539", "K964011", "K925214", "K963443", "K980137", "K931758", "K922133", "K935740", "K930270", "K892389", "K905004", "K885090", "K854095", "K871434", "K945831", "K925467", "K961683", "K871322", "K934688" ], "registration_number": [ "3008496560", "3006191977", "2024311", "3013502418", "3014680744", "3004911384", "3007329020", "3007082897", "3005012805", "3014925393", "1055892", "3012595397", "1054241", "2320762", "3006450239", "3013421458", "3026197444", "1060680", "3003495693", "3014325891", "3015173212", "3015058854", "3042158935", "3043620414", "3007139365", "3004513970", "3031841433", "3015895045", "3004362278", "3017430544", "3005246893", "9616088", "3011500469", "8022032", "3006271008", "1923569", "3035642068", "3004361903", "3013600605", "3042480961", "3020983482", "1123010", "1424263", "3045816907", "1423395", "1065597", "1422634", "1055236", "3006400329", "9611594", "3013735189", "3016761372", "3005400762", "3045857302", "1047429", "2000028362", "3007289408", "3006540014", "3004111573", "1643817", "1823410", "3010878085", "3007007790", "1063382", "3013466775", "3006846316", "3006542380", "1030451", "3004122598", "3010305275", "3006891803", "2431166", "1043214", "9680143", "1650907", "9680425", "1644019", "2648727", "3012811961", "9614277", "3002806603", "3016096096", "3036002406", "3014718111", "3011494917", "3018116884", "3011545608", "3019798849", "3009637528", "3027977504", "3014704068", "3013298431", "3003924117", "3002669946", "8022210", "3044906632", "1417592", "1921846", "3008403546", "3007829657", "3008824097", "1928237", "8030672", "1061124", "3011532690", "1824619", "2433012", "2029015", "3010376936", "2011171", "3030078769", "2024980", "1721686", "3011707784", "1000124971", "3017636737", "1610287", "9611024", "3011270181", "3010452421", "3005595283", "3006973666", "3041276890", "3007344957", "1055954", "1526711", "1047843", "8030678", "3009888344", "3013960812", "1527607", "1420054", "3011144486", "3002807314", "1423537", "3018077422", "2936485", "3045816902", "9681709", "3015960676", "3023140882", "3014421917", "9616096", "3011554160", "3005669815", "3018071447", "1121203", "3009773841", "1018470", "1066741", "3004713352", "3005997949", "3009750712", "3010166880", "3004605321", "2029275", "3017467279", "9680357", "3004519921", "3006673317", "3005391805", "3009203853" ], "fei_number": [ "3008496560", "3006191977", "2024311", "3013502418", "3014680744", "3004911384", "3007329020", "3007082897", "3005012805", "3014925393", "3012595397", "3006450239", "3013421458", "3002805559", "3004829691", "3026197444", "3003040625", "3003495693", "3000718854", "3014325891", "3015173212", "3015058854", "3042158935", "3043620414", "3007139365", "1000160458", "3004513970", "2523865", "3008373372", "3031841433", "3015895045", "3004362278", "3017430544", "3005246893", "3011500469", "3006271008", "1000306431", "3002807170", "1923569", "3035642068", "3004361903", "3013600605", "3042480961", "3020983482", "3005596530", "3045816907", "3006400329", "3013735189", "3016761372", "3005400762", "3045857302", "1047429", "2000028362", "3007289408", "3006540014", "3004111573", "1643817", "1823410", "3010878085", "3007007790", "3003807323", "3013466775", "3008875470", "3006542380", "3006846316", "1030451", "3004122598", "1000512168", "3010305275", "3001236905", "3006891803", "1043214", "1000112877", "1000123297", "3003015552", "1000112968", "2648727", "3012811961", "1000121355", "3002806603", "3016096096", "3036002406", "3018116884", "3011494917", "3011545608", "3019798849", "3009637528", "3027977504", "3014704068", "3013298431", "3932", "3003924117", "3002669946", "3002692512", "3044906632", "1000514656", "1417592", "1921846", "3008403546", "3002807308", "3007829657", "3008824097", "1928237", "1824619", "3011532690", "2433012", "3007596547", "3194", "3010376936", "2011171", "3030078769", "1721686", "3011707784", "1000124971", "3017636737", "1610287", "3000215259", "3011270181", "3010452421", "3005595283", "3006973666", "3001717360", "3041276890", "3002806436", "3007344957", "1526711", "1000208624", "3002681132", "1047843", "3003005156", "3009888344", "1000111202", "3013960812", "1527607", "1420054", "3011144486", "3002807314", "3005846326", "3018077422", "1000117501", "3000717925", "2936485", "3045816902", "3015960676", "3023140882", "3014421917", "3011554160", "3003803331", "3005669815", "3018071447", "3009773841", "1018470", "3004713352", "3005997949", "3009750712", "3010166880", "3002902735", "3004605321", "3017467279", "3005391805", "1000113384", "3009203853" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }