{ "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": "160526", "product_res_number": "Z-0321-2018", "event_date_initiated": "2017-03-15", "event_date_created": "2018-01-05", "recall_status": "Terminated", "event_date_terminated": "2018-12-17", "res_event_number": "78799", "product_code": "CAH", "k_numbers": [ "K973797" ], "product_description": "UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z,\tD360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6", "code_info": "1960762\t1960765\t1960769\t1960784\t1960787\t1960788\t1960789\t1960792\t1960800\t1960803\t1960804\t1961934\t1961935\t1961936\t1961937\t1961938\t1961940\t1961941\t1961942\t1961943\t1961945\t1961946\t1961951\t1961952\t1961953\t1961956\t1961957\t1961960\t1962253\t1962254\t1962256\t1962260\t1962261\t1962263\t1962264\t1962265\t1962266\t1962359\t1962360\t1962366\t1962368\t1962596\t1962609\t1962612\t1962613\t1962614\t1962615\t1962849\t1962852\t1962853\t1962855\t1962890\t1962891\t1962892\t1962893\t1962895\t1964378\t1964379\t1964380\t1964381\t1964383\t1964392\t1964394\t1964396\t1964399\t1964400\t1964677\t1964680\t1964699\t1964813\t1964819\t1964822\t1964825\t1964984\t1965377\t1965379\t1965386\t1965391\t1965393\t1965394\t1965919\t1965920\t1965921\t1965923\t1965924\t1965926\t1965927\t1965928\t1965929\t1965930\t1965931\t1965933\t1965939\t1965943\t1965946\t1965954\t1965956\t1965957\t1965958\t1965960\t1965961\t1965962\t1965963\t1966701\t1966702\t1966703\t1966704\t1966706\t1966707\t1967262\t1967265\t1967266\t1967267\t1967268\t1967269\t1967276\t1967382\t1967523\t1967525\t1967526\t1967528\t1967549\t1967550\t1967551\t1967552\t1967553\t1967554\t1968687\t1968689\t1968691\t1968692\t1968693\t1968694\t1968695\t1968696\t1968698\t1968704\t1968706\t1968707\t1968708\t1968709\t1968725\t1968726\t1968727\t1968728\t1968729\t1968730\t1968874\t1968875\t1968877\t1968879\t1968881\t1968882\t1968883\t1968892\t1968897\t1968898\t1969450\t1969451\t1969452\t1969453\t1969454\t1969467\t1969468\t1969470\t1970330\t1970382\t1970837\t1970882\t1970907\t1970909\t1970911\t1970912\t1970913\t1970914\t1970915\t1970916\t1970917\t1970918\t1970921\t1970924\t1970926\t1970927\t1970929\t1970930\t1970931\t1970932\t1970933\t1971683\t1971684\t1971688\t1971689\t1971690\t1971691\t1971692\t1971693\t1971694\t1971696\t1971698\t1971699\t1971706\t1971707\t1971708\t1971709\t1971710\t1971711\t1971713\t1971714\t1971716\t1971724\t1971725\t1971726\t1971727\t1971729\t1971730\t1971731\t1971735\t1971736\t1971737\t1971738\t1972360\t1972362\t1972363\t1972365\t1972372\t1972376\t1972377\t1972378\t1972379\t1972381\t1972382\t1972386\t1972388\t1972389\t1972391\t1972392\t1972393\t1972394\t1972399\t1972830\t1972831\t1972832\t1972833\t1972835\t1972836\t1972837\t1972840\t1972841\t1972843\t1972844\t1972845\t1972850\t1972852\t1972853\t1973970\t1973972\t1973977\t1973986\t1974000\t1974002\t1974546\t1974549\t1974550\t1974551\t1974684\t1974780\t1975089\t1975090\t1975091\t1975092\t1975093\t1975096\t1975097\t1975098\t1975104\t1975109\t1975110\t1975111\t1975112\t1975115\t1975118\t1975119\t1975120\t1975122\t1976072\t1976073\t1976074\t1976075\t1976084\t1976085\t1976086\t1976087\t1976718\t1976728\t1976729\t1976730\t1976733\t1976734\t1976735\t1976736\t1976737\t1976739\t1976934\t1976942\t1976943\t1976946\t1976947\t1976960\t1976962\t1977030\t1977034\t1977053\t1977151\t1977168\t1977176\t1977177\t1977865\t1977903\t1977904\t1977905\t1977909\t1977911\t1977912\t1977913\t1977915\t1977917\t1977920\t1977921\t1977923\t1977924\t1977926\t1977928\t1977932\t1977933\t1977934\t1978739\t1978795\t1978796\t1978797\t1978798\t1978799\t1978801\t1978802\t1978806\t1978807\t1978808\t1978835\t1978836\t1978838\t1978839\t1979219\t1979238\t1979239\t1979240\t1979241\t1979242\t1979243\t1979244\t1979245\t1979259\t1979342\t1979343\t1979346\t1979370\t1979372\t1979875\t1979890\t1979895\t1979898\t1979899\t1979900\t1979901\t1979902\t1979903\t1979904\t1979906\t1979907\t1979908\t1980972\t1980973\t1980975\t1980976\t1980978\t1980987\t1980991\t1980995\t1980998\t1980999\t1981001\t1981002\t1981004\t1981005\t1981006\t1981007\t1981008\t1981009\t1981010\t1981011\t1981022\t1981398\t1981399\t1981455\t1981456\t1981457\t1981458\t1981459\t1981463\t1981465\t1981469\t1982117\t1982125\t1982126\t1982129\t1982130\t1982132\t1982133\t1982136\t1982137\t1982138\t1982140\t1982142\t1982144\t1982147\t1982148\t1982149\t1982151\t1982157\t1982158\t1982159\t1982161\t1983477\t1983482\t1983486\t1984094\t1984097\t1984098\t1984099\t1984103\t1984104\t1984105\t1984268\t1984269\t1984270\t1984271\t1984273\t1984275\t1984277\t1984278\t1984285\t1984286\t1984290\t1984291\t1984293\t1984294\t1984295\t1984296\t1984297\t1985618\t1985620\t1985621\t1985624\t1985625\t1985632\t1985633\t1985636\t1985637\t1985638\t1985639\t1985960\t1985961\t1985962\t1985978\t1986136\t1986137\t1986138\t1986141\t1986142\t1986143\t1986220\t1986221\t1986222\t1986228\t1986229\t1986230\t1986300\t1986350\t1986360\t1986407\t1986408\t1986409\t1986410\t1986415\t1986418\t1986419\t1986420\t1986421\t1986422\t1986425\t1986426\t1986427\t1986428\t1986429\t1986430\t1987316\t1987317\t1987318\t1987325\t1987659\t1987660\t1987663\t1987664\t1987669\t1987911\t1987915\t1987917\t1987918\t1987919\t1987920\t1987921\t1987923\t1987924\t1987930\t1987932\t1988003\t1988004\t1988005\t1988008\t1988011\t1988368\t1988374\t1988375\t1988376\t1988380\t1988381\t1989233\t1989234\t1989235\t1989236\t1990044\t1990045\t1990046\t1992003\t1992024\t1992025\t1992026\t1992341\t1992343\t1992344\t1992348\t1992360\t1992362\t1992363", "firm_fei_number": "1824226", "recalling_firm": "King Systems Corp. dba Ambu, Inc.", "address_1": "15011 Herriman Blvd", "city": "Noblesville", "state": "IN", "postal_code": "46060-4253", "additional_info_contact": "317-776-6823", "reason_for_recall": "Potential for leak test failures.", "root_cause_description": "Nonconforming Material/Component", "action": "On 3/15/2017, the firm issued a letter to its sales force describing its intent to replace product for consignees that complained about leaking. The firm also issued a copy of the manifold IFU that includes the need for a 1/4 turn in the Universal Flex2 Breathing Circuit (with bacterial filter).", "product_quantity": "871,116 units", "distribution_pattern": "Distribution Pattern Distributors in 44 states: Al, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI WY; International Pattern - Canada, China, Chile", "openfda": { "k_number": [ "K063526", "K983610", "K011132", "K802914", "K925388", "K092451", "K871366", "K890035", "K964979", "K941676", "K151498", "K840205", "K961838", "K032322", "K934272", "K923661", "K884465", "K132709", "K811546", "K230483", "K893030", "K030071", "K802763", "K973238", "K061426", "K912577", "K121382", "K930816", "K223258", "K013089", "K964204", "K791773", "K833269", "K770375", "K930760", "K890346", "K780535", "K841236", "K210352", "K965016", "K911738", "K130664", "K792097", "K900990", "K812075", "K982127", "K833066", "K091363", "K934132", "K934540", "K853577", "K922492", "K896116", "K952062", "K252643", "K163300", "K072002", "K760611", "K903056", "K833267", "K211286", "K894978", "K840960", "K934189", "K952428", "K251583", "K092218", "K192713", "K043148", "K830618", "K941381", "K002839", "K012958", "K013122", "K000654", "K812098", "K925217", "K934475", "K911427", "K862790", "K964382", "K974630", "K760041", "K092409", "K023641", "K892520", "K850327", "K944189", "K842580", "K963053", "K844492", "K890362", "K820576", "K221250", "K052087", "K931842", "K944124", "K951484", "K101629", "K841581", "K221836", "K970102", "K896832", "K091185", "K901816", "K770136", "K760567", "K862785", "K012485", "K014282", "K862786", "K781696", "K892230", "K980662", "K030271", "K081536", "K880681", "K141087", "K961914", "K191909", "K941536", "K090738", "K915750", "K823257", "K190022", "K812573", "K931217", "K851070", "K031653", "K131626", "K032878", "K801803", "K983817", "K831856", "K133666", "K990949", "K801804", "K862787", "K221472", "K862789", "K050927", "K953687", "K112958", "K222917", "K850265", "K925462", "K132679", "K791307", "K945543", "K951047", "K121026", "K962045", "K093426", "K951410", "K002201", "K883693", "K895233", "K111408", "K790896", "K043120", "K030990", "K934509", "K013093", "K021020", "K820577", "K911651", "K772047", "K770376", "K021265", "K973314", "K952015", "K202459", "K032716", "K920885", "K770392", "K954490", "K844491", "K864103", "K002506", "K973797", "K014281", "K024270", "K904830", "K760081", "K901476", "K241339", "K033008", "K011212", "K954828", "K982239", "K063125", "K182862", "K010040", "K050953", "K013200", "K821310", "K943874", "K102483", "K832935", "K880958", "K965020", "K110246" ], "device_name": "Filter, Bacterial, Breathing-Circuit", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5260", "device_class": "2", "registration_number": [ "", "2936999", "1000604079", "2529776", "3005012805", "3010082909", "3018094310", "3008264065", "1054241", "2320762", "2024500", "1824226", "3011088743", "3007709321", "3010834934", "3027242374", "3044994756", "8040412", "9680602", "3006606984", "3003898360", "2132517", "3001313714", "3004874794", "3003332988", "3033959233", "3002807267", "3009747810", "1924066", "3011503227", "3020614", "3004476631", "3015134079", "3012365569", "3017520736", "3031369651", "8020893", "3045816907", "3005998497", "3009887154", "3017174574", "1055236", "2025816", "9616567", "3007289408", "3006061749", "3005587132", "3000268902", "3023294726", "9680661", "3004122598", "3010439239", "9614485", "3010877292", "3012821221", "3010042047", "3013557562", "1043214", "3011987967", "9681848", "1832562", "8010042", "3012316249", "8022265", "2648727", "3008693658", "2024841", "2433214", "3017202422", "3021244152", "3010131137", "3006254047", "3018116884", "3001124136", "3020777588", "3030446844", "9710644", "3005519819", "9615102", "3003862188", "3009896423", "3027977504", "3008311916", "3004365956", "3013242701", "3015191173", "8043316", "2518443", "1928237", "3011137372", "3007337939", "3006657376", "9617604", "3015537026", "3014936217", "3006534321", "8030673", "3004428458", "3010838917", "3004050971", "9710567", "3011707784", "3004116032", "3004127293", "3006157842", "3013530359", "8021995", "3006419626", "3010381606", "2085602", "2028807", "3006446479", "1024404", "1314417", "3015168843", "9611500", "3010402691", "3013095415", "3012494290", "3001104093", "3006783791", "2183585", "3012329712", "3003697063", "8044169", "3008412416", "3009171251", "3045816902", "3008567544", "1220253", "3008806809", "3005515211", "3014421917", "3003399703", "3005855942", "3017987980", "3013187142", "3009746061", "3021284283", "1526863", "3010889742", "3006673317", "9611451", "1722070" ], "fei_number": [ "", "2936999", "1000604079", "3005012805", "3010082909", "3018094310", "3008264065", "2024500", "3023530182", "1824226", "3002558692", "3011088743", "3003040625", "3007709321", "3010834934", "3027242374", "3044994756", "3006606984", "3003898360", "3004874794", "3003332988", "3033959233", "3002807267", "3009747810", "1924066", "3011503227", "3020614", "3004476631", "3015134079", "3012365569", "3017520736", "3031369651", "3005596530", "3045816907", "3002807293", "1000121196", "3005998497", "3009887154", "3017174574", "2025816", "3007289408", "3003256355", "3003949221", "3006061749", "3005587132", "3000268902", "3000213164", "3002807850", "3003319165", "3023294726", "3004122598", "3010439239", "3010877292", "3012821221", "3010042047", "3013557562", "1043214", "1000112877", "3011987967", "1832562", "3012316249", "1000112968", "2648727", "3008693658", "2024841", "2433214", "3002806988", "3017202422", "3021244152", "3010131137", "3006254047", "3018116884", "3001124136", "3020777588", "3030446844", "3005519819", "3003862188", "3009896423", "3027977504", "3008311916", "3004365956", "3002861325", "1000268645", "3013242701", "3015191173", "2518443", "1928237", "3007337939", "3006657376", "3015537026", "1000271197", "3014936217", "3006363476", "3006534321", "3006759904", "3004428458", "3010838917", "3004050971", "3011707784", "3004116032", "3004127293", "3006157842", "3013530359", "3006419626", "3010381606", "3006446479", "3002808696", "1024404", "1314417", "3015168843", "3010402691", "3013095415", "3012494290", "3001104093", "3006783791", "2183585", "3012329712", "3002673652", "3003697063", "1000221012", "3008412416", "3045816902", "3008567544", "3009271244", "1220253", "3008806809", "1000283452", "3002808128", "1000374126", "3005515211", "3014421917", "3002963732", "1000117260", "3003399703", "3005855942", "3017987980", "3013187142", "3009746061", "3021284283", "3000210616", "1526863", "3010889742", "3004213967", "3005747797" ] } } ] }