{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197053", "product_res_number": "Z-0881-2023", "event_date_initiated": "2022-11-01", "event_date_posted": "2023-01-04", "recall_status": "Open, Classified", "res_event_number": "91157", "product_code": "KDD", "product_description": "Various Custom Surgical Instrument Disposable Kits:\nPart Numbers / Product Description\n26000004M\tCustom Lasik Kit\nAMS10411A\tNasal Endoscopy Pack\nAMS10710A\tUltrasound Tray w/PDI\nAMS11941\tTotal Knee Pack\nAMS12138B\tEye Pack\nAMS12278B\tBody Pack\nAMS12341A\tHassan Pack\nAMS12341B\tHassan Pack\nAMS12343A\tMeldrum Pack\nAMS12359B\tNeuro Pack\nAMS12520\tTotal Hip Pack\nAMS12608\tExtremity Pack\nAMS12610\tShoulder Pack\nAMS12636\tDr. Thompson Pack\nAMS12689A\tCustom Pack\nAMS12753\tBreast Pack\nAMS12754\tAbdominoplasty Pack\nAMS12769\tMinor Pack\nAMS12926\tShoulder Pack\nAMS12927\tRetina Pack\nAMS13428\tHand Pack\nAMS2120D\tPlastics Tray\nAMS2890(B\tBasic Biopsy Tray\nAMS3824(A\tMyelogram Tray - RX\nAMS4022F\tLami Pack\nAMS4371C\tLasik Eye Pack\nAMS4372\tPlastic Eye Pack\nAMS4599(C\tSpine Pack\nAMS4670B\tUpper Extremity Pack\nAMS4766C\tShoulder Arthroscopy Pack\nAMS4952A\tVitrectomy Pack - RX\nAMS5697A\tEVLT Pack\nAMS5819B\tOrtho Major Pack\nAMS5887A\tCARS Pack\nAMS6112A\tMinor Extremity Pack\nAMS6112B\tMinor Extremity Pack\nAMS6160C\tHip Pack\nAMS6277A\tProcurement Bundle - Pack A/B/C\nAMS6728A\tBreast Pack\nAMS7463B\tRetrieval Pack\nAMS7971\tTVOR Pack\nAMS8094\tPlastics Eye Pack\nAMS8664B\tSpinal Pack\nAMS8989\tHysteroscopy Pack\nAMS9118\tRetrieval Pack\nAMS9197\tArthroscopy Pack\nAMS9435\tFoot Pack\nAMS9487A\tToy Hip Pack\nAMS9487B\tTotal Hip Pack\nCMP1018G\tCataract Kit - Dr. Wright\nPSS1838B\tMedical Imaging Kit\nVPP1020A\tCustom Dental Pack\nVPP1023B\tOR Implant Bundle Pack\nWAL1207C\tMinor Pack", "code_info": "Part Numbers / Product Description / UDI Code:\n26000004M\tCustom Lasik Kit\tB09826000004M0\nLot Numbers\n172743\n175939\n178701\n\nAMS10411A\tNasal Endoscopy Pack\tB098AMS10411A0\nLot Numbers\n167289\n171449\n176800\n\nAMS10710A\tUltrasound Tray w/PDI\tB098AMS10710A0\nLot Numbers\n165400\n170502\n172266\n174545\n178063\n\nAMS11941\tTotal Knee Pack\tB098AMS119410\nLot Numbers\n167985\n172632\n\nAMS12138B\tEye Pack\tB098AMS12138B0\nLot Number\n173532\n\nAMS12278B\tBody Pack\tB098AMS12278B0\nLot Numbers\n169016\n171534\n173220\n174960\n176107\n178175\n\nAMS12341A\tHassan Pack\tB098AMS12341A0\nLot Number\n167836\n\nAMS12341B\tHassan Pack\tB098AMS12341B0\nLot Numbers\n170376\n176035\n178108\n\nAMS12343A\tMeldrum Pack\tB098AMS12343A0\nLot Numbers\n169907\n173805\n178357\n\nAMS12359B\tNeuro Pack\tB098AMS12359B0\nLot Numbers\n169315\n174926\n177785\n\nAMS12520\tTotal Hip Pack\tB098AMS125200\nLot Number\n172089\n\nAMS12608\tExtremity Pack\tB098AMS126080\nLot Numbers\n167069\n167271\n171686\n172416\n173221\n175365\n\nAMS12610\tShoulder Pack\tB098AMS126100\nLot Numbers\n165469\n176734\n179262\n\nAMS12636\tDr. Thompson Pack\tB098AMS126360\nLot Numbers\n169693\n169902\n170466\n173025\n174576\n176208\n177411\n180470\n\nAMS12689A\tCustom Pack\tB098AMS12689A0\nLot Numbers\n169549\n171027\n172750\n173642\n175088\n176507\n177771\n179109\n180349\n\nAMS12753\tBreast Pack\tB098AMS127530\nLot Numbers\n168384\n171578\n176335\n\nAMS12754\tAbdominoplasty Pack\tB098AMS127540\nLot Numbers\n168546\n171086\n\nAMS12769\tMinor Pack\tB098AMS127690\nLot Numbers\n169398\n170647\n173968\n176964\n\nAMS12926\tShoulder Pack\tB098AMS129260\nLot Numbers\n172790\n176337\n\nAMS12927\tRetina Pack\tB098AMS129270\nLot Numbers\n172376\n177356\n177598\n180851\n181069\n\nAMS13428\tHand Pack\tB098AMS134280\nLot Number\n173569\n\nAMS2120D\tPlastics Tray\tB098AMS2120D0\nLot Numbers\n174742\n176986\n\nAMS2890(B\tBasic Biopsy Tray\tB098AMS2890B0\nLot Numbers\n174253\n176930\n182598\n\nAMS3824(A\tMyelogram Tray - RX\tB098AMS3824A0\nLot Number\n177781\n\nAMS4022F\tLami Pack\tB098AMS4022F0\nLot Numbers\n168799\n168800\n168801\n169653\n171413\n171414\n172773\n173794\n174413\n177139\n177377\n177705\n177847\n177849\n178356\n178358\n179492\n179493\n180260\n\nAMS4371C\tLasik Eye Pack\tB098AMS4371C0\nLot Number\n170046\n\nAMS4372\tPlastic Eye Pack\tB098AMS43720\nLot Numbers\n176026\n177332\n\nAMS4599(C\tSpine Pack\tB098AMS4599C0\nLot Numbers\n171036\n175421\n\nAMS4670B\tUpper Extremity Pack\tB098AMS4670B0\nLot Numbers\n167606\n168422\n169687\n170683\n171243\n173309\n174050\n176846\n178154\n178842\n\nAMS4766C\tShoulder Arthroscopy Pack\tB098AMS4766C0\nLot Numbers\n168066\n172365\n177179\n\nAMS4952A\tVitrectomy Pack - RX\tB098AMS4952A0\nLot Number\n169163\n\nAMS5697A\tEVLT Pack\tB098AMS5697A0\nLot Numbers\n171342\n173848\n175135\n176504\n\nAMS5819B\tOrtho Major Pack\tB098AMS5819B0\nLot Numbers\n168686\n171146\n173713\n\nAMS5887A\tCARS Pack\tB098AMS5887A0\nLot Numbers\n169593\n171040\n171147\n172229\n173448\n174473\n175005\n175424\n177023\n178038\n178420\n179311\n\nAMS6112A\tMinor Extremity Pack\tB098AMS6112A0\nLot Number\n172500\n\nAMS6112B\tMinor Extremity Pack\tB098AMS6112B0\nLot Number\n171559\n\nAMS6160C\tHip Pack\tB098AMS6160C0\nLot Numbers\n161888\n173087\n174177\n177151\n179592\n179958\n\nAMS6277A\tProcurement Bundle - Pack A/B/C\tB098AMS6277A0\nLot Numbers\n172168\n175828\n176688\n177169\n178508\n179705\n180063\n\nAMS6728A\tBreast Pack\tB098AMS6728A0\nLot Numbers\n164967\n180654\n\nAMS7463B\tRetrieval Pack\tB098AMS7463B0\nLot Numbers\n168899\n169309\n170342\n171177\n171639\n172537\n174848\n175470\n\nAMS7971\tTVOR Pack\tB098AMS79710\nLot Numbers\n166641\n167921\n171195\n172400\n174680\n176100\n177940\n181505\n\nAMS8094\tPlastics Eye Pack\tB098AMS80940\nLot Numbers\n163893\n174604\n\nAMS8664B\tSpinal Pack\tB098AMS8664B0\nLot Numbers\n167532\n170219\n176124\n177880\n178872\n\nAMS8989\tHysteroscopy Pack\tB098AMS89890\nLot Numbers\n174335\n178486\n\nAMS9118\tRetrieval Pack\tB098AMS91180\nLot Numbers\n166923\n167457\n171149\n171732\n172838\n175210\n176358\n177149\n178422\n180157\n\nAMS9197\tArthroscopy Pack\tB098AMS91970\nLot Numbers\n167533\n172585\n175376\n\nAMS9435\tFoot Pack\tB098AMS94350\nLot Numbers\n169981\n171340\n172021\n176479\n\nAMS9487A\tToy Hip Pack\tB098AMS9487A0\nLot Number\n170102\n\nAMS9487B\tTotal Hip Pack\tB098AMS9487B0\nLot Numbers\n168578\n170106\n173336\n173337\n177471\n177472\n178074\n178966\n179594\n\nCMP1018G\tCataract Kit - Dr. Wright\tB098CMP1018G0\nLot Numbers\n169450\n170960\n\nPSS1838B\tMedical Imaging Kit\tB098PSS1838B0B\nLot Numbers\n169452\n169680\n173823\n175798\n175799\n176797\n177249\n178693\n179849\n\nVPP1020A\tCustom Dental Pack\tB098VPP1020A0\nLot Number\n171822\n\nVPP1023B\tOR Implant Bundle Pack\tB098VPP1023B0\nLot Numbers\n167562\n171238\n173828\n\nWAL1207C\tMinor Pack\tB098WAL1207C0\nLot Numbers\n169769\n170157\n170629\n172288\n174937\n176517\n177772", "firm_fei_number": "1000125955", "recalling_firm": "Windstone Medical Packaging, Inc.", "address_1": "1602 4th Ave N", "city": "Billings", "state": "MT", "postal_code": "59101-1521", "additional_info_contact": "Jeff Jensen\n406-259-6387", "reason_for_recall": "Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.", "root_cause_description": "Component change control", "action": "On 11/01/2022, firm emailed an \"URGENT: MEDICAL DEVICE RECALL\" Letter was emailed to customers informing them that Align Medical Solutions Convenience Kits were being recalled due to kits containing 3M Steri-Drape Surgical Drapes that have an adhesive component that is difficult to remove without damaging the drape and may render the product unusable.\n\nCustomers are instructed to:\n1. Immediately check their inventory and place affected products under quarantine.\n2. Due to the manufacturing process, any finished sterilized packs remaining in inventory, or at their facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack that reads:\nRECALL NOTICE - 3M announced the recall of 3M Steri-Drape Surgical Drape(s) contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall.\n1. At the time the kit is opened for use any 3M Steri-Drape Surgical Drape(s) should be identified and set aside.\n2. The recalled 3M Steri-Drape Surgical Drape(s) should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.\n\nFor questions or concerns contact - fieldcorrectiveaction@alignedmedicalsolutions.com or vdavis@alignedmedicalsolutions.com", "product_quantity": "9,489 kits", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.", "openfda": { "k_number": [ "K870373", "K803117", "K911606", "K761193", "K920516", "K923176", "K871458", "K874063", "K803119", "K925215", "K971317", "K770149", "K832047", "K821814", "K920763", "K780336", "K833075", "K802019", "K821501", "K910366", "K803118", "K834135", "K811855", "K925905", "K011514", "K771448", "K832628", "K864969", "K760051", "K822158", "K924958", "K924117", "K813103", "K843115", "K831795", "K850325", "K811086", "K803199", "K802557", "K853910", "K833438", "K913049", "K072814", "K842627", "K843206", "K830374", "K914244", "K902441", "K910369", "K821502", "K834532", "K932219", "K802017", "K821500", "K920989", "K880785", "K910816", "K960456", "K780488", "K831841", "K936255", "K820423" ], "registration_number": [ "3004941127", "1820334", "3004464325", "3007007790", "3005273623", "3011680076", "3011280379", "3009512503", "3011499367", "3004638532", "3010353405", "3010583458", "1221934", "9617977", "3009340886", "3010900528", "3007697249", "3011445359", "3003431869", "1043534", "3006554788", "3006128100", "1526711", "9681465", "3005108347", "1928237", "3009189869", "3009889060", "8044099", "3015183635", "3008650117", "3044571218", "3005515211", "3014644369", "8010273", "3005675811", "1211566", "3013298431", "3017406171", "3011525245", "3007123908", "1030451", "3006638824", "3042158827", "3025686427", "3013840437", "2648666", "3018094310", "3003139373", "3005440795", "3015416207", "2011068", "3035642068", "2027062", "3018503755", "3010178296", "3006673317", "3013530901", "3003604053", "3022320321", "3003597504", "3010659131", "3015058854", "3020468145", "3008559295", "3010536692", "3010470577", "3007139365", "3002807115", "3021006167", "9617229", "3014457631", "3015309643", "1836161", "3032579548", "2025182", "3016195240", "3008812560", "2320762", "1219602", "3013680140", "3030516433", "3004892425", "3006950086", "1423395", "3004365956", "3012130008", "3018544165", "3012568936", "3015487912", "2953359", "3006260740", "2648623", "1718873", "1935627", "3017937325", "3004992978", "3010531069", "1825034", "9615765", "3015225571", "3025168", "3010452421", "2433012", "3017194442", "1420054", "9680794", "1450662", "3033589330", "1061124", "1313525", "3003807268", "3010459874", "3010667733", "3007329020", "3033509898", "2029275", "3008114965", "3003759558", "3012187635", "1643116", "3008936260", "3029754081", "3015859709", "3010155661", "3003477135", "3041276415", "3038220293", "3011707784", "1422634", "3023191945", "3016068274", "2245270", "3022862651", "3032747418", "2024311", "1226074", "1423537", "2022435", "3009513193", "2530138", "1123010", "3016215282", "3031180770", "3028002947", "1721676", "3017607477", "3004122598", "3010273872", "3006617885", "3008902714", "2032112", "3012478585", "3043648115", "3009703496", "3015173212", "3005595283", "3015895045", "3012358417", "3009746061", "9613083", "1824619", "1220477", "3007607706", "1018470", "3013503739", "3034629649", "3001084743", "3010380518", "1048735", "3010760216", "1721504", "3009996260", "8040278", "3014637079", "3013307971", "2029015", "3008808049", "1643817", "3004605321", "3018116884", "3036756245", "3008627763", "3008467060", "3045857302", "3002807310", "9614841", "3006191977", "3003960560", "2936485", "3010170586", "3029082594", "1017294", "3009495876", "3004111573", "3014314985", "3014383382", "3014615028", "3030680364", "3010462278", "3025603301", "1121091", "3007597038", "1526534", "3005325790", "3022132808", "3006460162", "3017538679", "3005897698", "1225691", "3021332749", "3016874083", "3017952668", "3017059795", "1061927", "1649518", "1038671", "3014421917", "3017860875", "1060680", "1417592", "3011089435", "3006271008", "3004125670", "9616088", "3016733629", "2649614", "1123137", "3016248648", "3010370474", "3045058049", "3015337348", "3013421458", "2183744", "3011585752", "3003528228", "1000614268", "3009888344", "1064371", "3007420745", "3005669815", "3011237770", "3014146451", "3039406055", "2032098", "3023464160", "3003882387", "1211998", "3002834291", "3008258694", "3033796310", "3023265483", "3013756169", "3010060157", "3006098219", "3030067857", "1422598", "3027807601", "3004598675", "3013980229", "1054811", "2245304", "1032347", "1424263", "3010610950", "3017461134", "3013002167", "3016170492", "3006542380", "3007593722", "3005083075", "3008338766", "3034676720", "9681540", "1222773", "3013666218", "3013466775", "1125782", "3006946102", "3017896419", "3007663067", "2246552", "3023339277", "9612327", "1721686", "3045816907", "3015745029", "1223004", "3010041511", "3004513970", "3011862887", "3045816902", "3014257280", "1219930", "2431166", "8020785", "1034876", "3011137372", "9616872", "1043214", "1047843", "3039169546", "1319639", "3008824097", "3016171914", "3018781093", "1035236", "3010052483", "3013443304", "3005034064", "1526611", "8043792", "3002808466", "9611024", "1055236", "3012536737", "3008676146", "3007681502", "3004519921", "3010131137", "3019798849", "3039414397", "9680002", "3016826509", "3031184338", "8030607", "3015143057", "3030681106", "1058584", "1054241", "3008132398", "3006633581", "2135156", "3006217744", "2531684", "3043620689" ], "fei_number": [ "3004941127", "2523865", "1820334", "3004464325", "3007007790", "3005273623", "3011680076", "3011280379", "3009512503", "3011499367", "3004638532", "1000221205", "3010353405", "3010583458", "1221934", "3002750084", "3009340886", "3010900528", "3007697249", "3011445359", "3003110073", "3003431869", "1043534", "3006554788", "3006128100", "1526711", "1928237", "3009189869", "3006108784", "3009889060", "3015183635", "3008650117", "3044571218", "3002807113", "3005515211", "3014644369", "3003076831", "3005675811", "3002616700", "1211566", "3013298431", "3017406171", "3011525245", "3007123908", "1030451", "3006638824", "3042158827", "3025686427", "3013840437", "2648666", "3003737899", "3018094310", "3005596530", "3003139373", "3005440795", "3015416207", "2011068", "3035642068", "1000220280", "2027062", "3018503755", "3013530901", "3003604053", "3022320321", "3000203000", "3003597504", "3010659131", "3015058854", "3020468145", "3008559295", "3010536692", "3010470577", "3007139365", "3001236277", "3002807115", "3021006167", "3014457631", "3015309643", "3032579548", "2025182", "3016195240", "3008812560", "1219602", "3002902735", "3013680140", "3030516433", "3004892425", "3006950086", "3004216008", "3004365956", "3012130008", "1317628", "3018544165", "3012568936", "3002807682", "3015487912", "1000208624", "3006260740", "2648623", "1718873", "1935627", "3002897187", "3017937325", "3004992978", "3010531069", "1825034", "3015225571", "1000125955", "3002808269", "3003179719", "3010452421", "2433012", "1000160458", "3017194442", "1420054", "1450662", "3033589330", "3003807268", "3010459874", "3010667733", "3003756816", "3007329020", "1000123180", "3001451466", "3033509898", "3008114965", "3003759558", "3012187635", "1643116", "3008936260", "3029754081", "3009291251", "3002975287", "3015859709", "3010155661", "3003477135", "3001236905", "3041276415", "3038220293", "3011707784", "3023191945", "3016068274", "2245270", "3022862651", "3032747418", "2024311", "2022435", "3009513193", "3016215282", "3031180770", "3000321209", "3028002947", "1721676", "3017607477", "3004122598", "3010273872", "3006617885", "3008902714", "3012478585", "3043648115", "4486", "3009703496", "3015173212", "3005595283", "3015895045", "3002681225", "3012358417", "3009746061", "1824619", "1220477", "3007607706", "1000306431", "1018470", "3013503739", "3034629649", "3001084743", "3010380518", "1048735", "3010760216", "1721504", "3009996260", "3014637079", "3013307971", "1000120555", "3008808049", "1643817", "3002808360", "3004605321", "3018116884", "3036756245", "3008627763", "3008467060", "3045857302", "3002807310", "3006191977", "3003960560", "2936485", "3000215205", "3010170586", "3029082594", "1017294", "3009495876", "3004111573", "3002807445", "3014314985", "3014383382", "3014615028", "3030680364", "3010462278", "3002535141", "3025603301", "1121091", "1000514656", "1526534", "3005325790", "3022132808", "3006460162", "3017538679", "3005897698", "3021332749", "3016874083", "3017952668", "1000112968", "3017059795", "1000120768", "1038671", "3014421917", "3017860875", "1417592", "3011089435", "3006271008", "3004125670", "1000512168", "3004458261", "3016733629", "3003015552", "3002808402", "2649614", "3003058448", "3016248648", "3010370474", "3045058049", "3015337348", "3013421458", "2183744", "3011585752", "3003528228", "1000614268", "3009888344", "3007420745", "3005669815", "3003040625", "3011237770", "3014146451", "3039406055", "3023464160", "3003882387", "1211998", "3002834291", "3008258694", "3033796310", "3023265483", "3013756169", "3010060157", "3006098219", "3030067857", "3027807601", "3004598675", "3013980229", "2245304", "1032347", "1000138054", "3010610950", "3017461134", "1000123297", "3013002167", "3016170492", "3006542380", "3007593722", "3005083075", "3008338766", "3034676720", "1000112877", "1000114185", "3013466775", "3013666218", "1000219637", "3005846326", "1000347621", "3006946102", "3017896419", "3007663067", "2246552", "3023339277", "1721686", "3045816907", "3015745029", "3010041511", "3004513970", "3011862887", "3045816902", "3014257280", "1219930", "1034876", "1043214", "1047843", "3039169546", "3008824097", "3016171914", "3018781093", "1035236", "3010052483", "3013443304", "3005034064", "1526611", "3002808466", "3012536737", "3008676146", "3007681502", "3002865793", "3010131137", "3002807091", "3006509795", "3019798849", "3002807170", "3039414397", "3016826509", "3031184338", "3015143057", "3030681106", "3006633581", "3005747797", "3006217744", "3000717925", "3043620689" ], "device_name": "Kit, Surgical Instrument, Disposable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }