{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219191", "product_res_number": "Z-2202-2026", "event_date_initiated": "2026-04-08", "event_date_posted": "2026-05-15", "recall_status": "Open, Classified", "res_event_number": "98603", "product_code": "DYB", "k_numbers": [ "K231248", "K233824" ], "product_description": "Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;", "code_info": "Model/UDI-DI/Lot(Expiration): 131F7P/00690103000412/65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026),65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 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66873884(8/2/2027), 66873885(8/5/2027), 66873886(8/18/2027), 66895223(8/20/2027), 66938771(8/22/2027), 66938772(8/26/2027), 66938773(8/27/2027), 66964710(9/1/2027), 66964711(9/4/2027), 66982688(9/26/2027), 67025469(10/20/2027), 67047800(10/17/2027), 67047801(10/21/2027), 67068446(10/28/2027), 67092101(10/28/2027), 67098252(10/30/2027), 67098253(11/3/2027), 67199591(11/12/2027), 67199595(11/13/2027), 67199596(11/11/2027), 67199617(11/21/2027), 67199618(11/22/2027), 67217934(1/7/2028), 67217935(12/4/2027), 67266297(1/12/2028), 67275624(12/20/2027), 67275626(12/3/2027), 67322713(1/13/2028), 67322714(1/16/2028), 67357488(1/29/2028), 67395549(2/5/2028), 67395555(1/28/2028), 66739917(6/12/2027);\n\n131F7/00690103000405/ 65902900(8/1/2026), 65902901(8/3/2026), 65910728(8/2/2026), 65910729(7/29/2026), 65910730(7/27/2026), 65910731(7/25/2026), 65910732(7/26/2026), 65910735(7/30/2026), 65910736(8/24/2026), 65910737(7/31/2026), 65916927(8/3/2026), 65916928(8/6/2026), 65916929(8/7/2026), 65916930(8/8/2026), 65916931(8/9/2026), 65916932(8/22/2026), 65916933(8/23/2026), 65944791(8/20/2026), 65944792(8/21/2026), 65955857(9/9/2026), 65955858(9/17/2026), 65955859(9/26/2026), 65955860(9/27/2026), 65973739(9/5/2026), 65973740(9/6/2026), 65973741(9/7/2026), 65973742(9/10/2026), 65988571(9/28/2026), 65997478(9/16/2026), 65997479(9/17/2026), 65997481(9/19/2026), 65997482(9/20/2026), 66010504(9/10/2026), 66010505(9/11/2026), 66010506(9/12/2026) ,66010507(9/13/2026) ,66010508(9/14/2026) ,66023074(9/30/2026) ,66033088(10/5/2026) ,66048930(10/9/2026), 66057629(10/6/2026), 66057630(10/8/2026), 66057944(10/15/2026), 66057945(10/17/2026), 66061552(10/24/2026), 66074999(10/4/2026), 66075318(11/19/2026), 66104892(10/21/2026), 66104893(10/22/2026), 66104894(10/23/2026), 66104895(11/13/2026), 66108277(11/15/2026), 66118638(11/22/2026), 66120310(10/29/2026), 66120312(10/30/2026), 66120313(10/31/2026), 66127027(11/15/2026), 66127028(11/20/2026),66132570(11/21/2026), 66132571(11/25/2026), 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66439368(3/26/2027), 66439369(3/31/2027), 66439370(4/2/2027), 66439371(4/7/2027), 66439372(4/9/2027), 66488597(5/28/2027),66521743(4/16/2027), 66529338(4/15/2027), 66529339(4/21/2027), 66529340(4/22/2027), 66529341(4/23/2027),66529345(5/23/2027),66544240(4/24/2027), 66594945(5/14/2027), 66597237(4/29/2027),66597238(4/30/2027), 66597239(5/10/2027), 66601166(5/2/2027), 66601167(5/8/2027), 66601168(5/12/2027), 66601169(5/13/2027), 66601170(5/14/2027), 66601171(5/29/2027), 66642726(5/9/2027), 66692566(6/6/2027), 66704724(6/4/2027), 66710839(6/2/2027), 66710840(6/3/2027), 66739812(6/13/2027),66739813(6/18/2027), 66739814(6/17/2027), 66739910(6/24/2027), 66739911(7/17/2027), 66739912(7/9/2027), 66739913(6/16/2027), 66739916(6/23/2027), 66740114(7/17/2027), 66758828(7/10/2027), 66767282(6/28/2027), 66769651(7/18/2027), 66782067(7/21/2027), 66826029(7/23/2027),66826030(7/24/2027), 66832079(7/25/2027), 66844048(7/31/2027), 66873884(8/2/2027), 66873885(8/5/2027), 66873886(8/18/2027), 66895223(8/20/2027), 66938771(8/22/2027), 66938772(8/26/2027), 66938773(8/27/2027), 66964710(9/1/2027), 66964711(9/4/2027), 66982688(9/26/2027), 67025469(10/20/2027), 67047800(10/17/2027), 67047801(10/21/2027), 67068446(10/28/2027), 67092101(10/28/2027), 67098252(10/30/2027), 67098253(11/3/2027), 67199591(11/12/2027), 67199595(11/13/2027), 67199596(11/11/2027), 67199617(11/21/2027), 67199618(11/22/2027), 67204649(12/4/2027), 67217934(1/7/2028), 67217935(12/4/2027), 67266297(1/12/2028), 67268374(12/3/2027), 67275624(12/20/2027), 67275626(12/3/2027), 67322713(1/13/2028), 67322714(1/16/2028), 67357488(1/29/2028), 67395549(2/5/2028), 67395555(1/28/2028);\n\n131F7J/67268374(12/3/2027);\n\n141F7/00690103000504/ 65891632(8/5/2026), 65891637(8/20/2026), 65916934(8/19/2026), 65916935(8/26/2026), 65944795(8/27/2026), 65955863(8/27/2026), 65973744(9/9/2026), 65988572(9/18/2026), 65997483(10/1/2026), 66023075(10/4/2026), 66023076(10/28/2026), 66033077(10/25/2026), 66061553(10/26/2026), 66273575(2/13/2027), 66315690(3/8/2027), 66378397(3/20/2027), 66414675(3/28/2027), 66414681(5/30/2027), 66465246(4/23/2027), 66552320(4/29/2027), 66594946(4/28/2027), 66623671(5/1/2027), 66644932(5/16/2027), 66739789(6/26/2027), 66767253(6/30/2027), 66809856(7/4/2027), 66809857(7/7/2027), 66812062(7/8/2027), 66826050(7/30/2027), 66873887(7/29/2027), 66945954(8/26/2027), 67014463(12/19/2026), 67056072(9/22/2027);\n\n151F7/00690103000566/ 66001841(8/29/2026), 66003074(9/14/2026), 66003075(9/7/2026), 66017563(9/21/2026), 66081903(10/3/2026), 66081904(11/1/2026), 66106780(10/25/2026), 66108265(11/7/2026), 66174936(12/17/2026), 66351108(3/6/2027), 66351109(3/12/2027), 66351111(3/21/2027), 66384522(3/29/2027), 66439364(4/4/2027), 66471244(4/11/2027), 66544241(4/24/2027), 66552321(5/2/2027), 66594947(5/9/2027), 66615747(5/14/2027), 66616064(6/27/2027), 66643585(5/21/2027), 66670993(8/7/2027), 66710846(6/6/2027), 66758827(8/1/2027), 66809858(8/6/2027), 66809859(9/11/2027), 66809860(9/20/2027), 66889370(8/26/2027), 66972526(10/3/2027), 67197204(11/20/2027), 67197205(11/28/2027);\n834F75/00690103151756/ 66149781(11/20/2026), 66169452(11/21/2026), 66169453(11/22/2026), 66169454(11/22/2026), 66225269(1/17/2027), 66292951(2/6/2027), 66295865(2/25/2027), 66325010(2/21/2027), 66358925(2/25/2027), 66360368(2/24/2027), 66384531(3/21/2027), 66384532(3/21/2027), 66384533(3/31/2027), 66419531(3/15/2027), 66597740(4/25/2027), 66704730(6/6/2027), 66710835(10/16/2027), 66739754(7/2/2027), 66748559(6/11/2027), 66748561(6/10/2027), 66829581(7/5/2027), 66832094(8/1/2027), 66894451(7/31/2027), 66894452(8/1/2027), 66987645(8/30/2027), 67025475(10/13/2027), 67045003(9/17/2027), 67047807(10/14/2027), 67075111(9/27/2027), 67197192(11/11/2027), 67205219(11/18/2027);\n\n096F6, 096F6P/00690103000245, 00690103218602/66687312(6/9/2027), 66687922(6/10/2027), 66687924(6/13/2027), 66780053(6/26/2027), 66822159(9/22/2027);\n\n\nC144F7/00690103005134/66822158(7/15/2027);\n\n\n782F75M/00690103197303/66725374(6/19/2027);\n\n\n132F5/00690103000467/66687936(6/9/2027), 66467271(6/9/2027);\n\n\nC146F7/00690103153132;\n\n831F75P/831F75-00690103003031, 00690103218282/66175089(11/26/2026), 66175090(12/2/2026), 66175091(12/2/2026), 66175092(12/3/2026), 66175093(11/26/2026), 66175094(11/27/2026), 66175095(11/28/2026), 66175096(11/29/2026), 66175097(11/29/2026), 66175103(12/4/2026), 66175104(12/5/2026), 66175105(12/5/2026), 66175120(12/9/2026), 66175121(12/10/2026), 66175122(12/11/2026), 66208306(12/12/2026), 66208323(12/13/2026), 66211381(12/16/2026), 66211385(1/8/2027), 66211386(1/9/2027), 66225264(1/13/2027), 66225265(1/14/2027), 66225266(1/15/2027), 66225267(1/16/2027), 66225268(1/22/2027), 66268847(1/23/2027), 66278675(2/5/2027), 66283844(2/14/2027), 66283845(2/26/2027), 66283846(2/20/2027), 66296223(3/3/2027), 66298719(3/1/2027), 66301299(2/17/2027), 66301300(2/19/2027), 66439365(4/3/2027), 66439366(4/5/2027), 66439367(4/11/2027), 66488586(3/28/2027), 66529347(5/31/2027), 66554378(4/12/2027), 66591113(5/2/2027), 66660610(5/20/2027), 66664653(5/21/2027), 66667556(5/17/2027), 66667557(5/19/2027), 66704725(6/5/2027), 66704758(6/27/2027), 66739799(7/15/2027), 66758829(7/11/2027), 66759128(6/12/2027), 66767284(6/25/2027), 66782068(7/28/2027), 66804400(6/30/2027), 66804401(7/2/2027), 66804402(7/3/2027), 66826032(7/26/2027), 66873891(8/8/2027), 66934651(8/23/2027), 66934677(8/29/2027), 66964714(8/25/2027), 66972587(9/18/2027), 66972588(9/22/2027), 67003703(9/30/2027), 67003704(10/1/2027), 67005151(9/9/2027), 67005156(9/3/2027), 67005540(10/7/2027), 67005541(10/9/2027), 67005542(9/10/2027), 67005543(9/11/2027), 67005544(9/23/2027), 67005545(10/10/2027), 67184885(11/1/2027);\n\nTS105F5/00690103018295;\n\n774F75/00690103146998/66521746(5/7/2027), 66844440(7/8/2027), 66844441(7/9/2027), 66844442(7/10/2027), 66844443(7/11/2027), 66844444(7/11/2027), 66844445(7/12/2027), 66844446(7/14/2027), 66844447(7/15/2027), 66844448(7/15/2027), 66844449(7/16/2027), 66844450(7/16/2027), 66844451(7/17/2027), 66844452(7/18/2027), 66844453(8/4/2027), 66919298(8/6/2027), 66919299(8/20/2027), 66920022(8/5/2027);\n\n777F8/00690103146554/66417428(4/21/2027), 66417429(4/22/2027), 66417430(4/22/2027), 66419577(4/11/2027), 66419578(4/12/2027), 66419579(4/14/2027), 66419580(4/14/2027), 66419581(4/15/2027), 66419582(4/15/2027), 66419583(4/16/2027), 66419584(4/16/2027), 66419585(4/21/2027), 66438181(4/23/2027), 66465249(4/25/2027), 66523321(4/23/2027), 66523328(4/24/2027), 66523330(4/28/2027), 66523331(4/25/2027), 66544242(4/30/2027), 66568201(5/7/2027), 66590392(5/12/2027), 66600645(4/28/2027), 66600646(4/29/2027), 66600647(4/29/2027), 66600648(4/30/2027), 66600649(4/30/2027), 66615750(5/1/2027), 66615751(5/3/2027), 66615752(5/19/2027), 66615753(5/20/2027), 66619148(5/2/2027), 66643587(5/22/2027), 66643588(5/23/2027), 66643589(5/26/2027), 66643590(5/27/2027), 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66417073(3/23/2027), 66437580(3/28/2027);", "firm_fei_number": "3032916632", "recalling_firm": "Becton, Dickinson and Company", "address_1": "17200 Laguna Canyon Rd", "city": "Irvine", "state": "CA", "postal_code": "92618-5403", "reason_for_recall": "Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.", "root_cause_description": "Process change control", "action": "On 4/8/2026, mailed correction notices were mailed to customers and distributors who were informed of the following:\n\nConsider the following to reduce the potential for hub breakage issues.\n Minimize manipulation of proximal injectate hub and lumen.\n Pay frequent attention to the (blue) proximal injectate lumen for leakage or breakage, and exchange with another catheter if the issue is encountered.\n Modify existing clinical workflows to minimize flexing and stress of (blue) proximal injectate lumen. For example:\no Securing the catheter lumens to an IV arm board to mitigate bending/flexing of the\nlumen(s)\no Consider using the stopcock on white hub to allow for intermittent transducer pressure tubing changes without twisting white hub on Swan Ganz (blue) proximal injectate lumen.\no Prevent CO-Set syringe and proximal injectate lumen from dangling/hanging without\nsupport.\no Change to automated cardiac output models to mitigate device stress.\n Providers and institutions may choose to utilize transthoracic or transesophageal echocardiography in combination with techniques to monitor central venous pressure via a central venous catheter in patients in need of right ventricle monitoring and management.\n Converting to Acumen IQ / FloTrac sensor can provide continuous minimally invasive\nhemodynamic monitoring from the arterial line. \nConsider using ClearSight cuff for continuous non-invasive hemodynamic monitoring.\nDistributors should forward the correction notice to customers who have purchased the impacted product.\nComplete and return the acknowledgement form via email to SMB-FCAUSAPM@bd.com\n\nQuestions can be directed to the firm's Customer Service at (800) 424-3278", "product_quantity": "589,223", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.", "openfda": { "k_number": [ "K101784", "K242756", "K140201", "K925633", "K140768", "K932323", "K771042", "K073434", "K873394", "K140917", "K140287", "K101883", "K160721", "K961780", "K902477", "K240004", "K942977", "K912664", "K902275", "K132164", "K212708", "K190644", "K982740", "K893658", "K915553", "K111606", "K992309", "K080500", "K103083", "K930057", "K844840", "K213492", "K984062", "K162097", "K221655", "K863139", "K924607", "K022689", "K171820", "K233708", "K860307", "K871140", "K012922", "K190688", "K071574", "K903410", "K210627", "K042308", "K001367", "K830813", "K993191", "K800356", "K060666", "K130559", "K870542", "K092014", "K011761", "K112407", "K813019", "K091006", "K990705", "K981909", "K260839", "K090114", "K904475", "K130730", "K981782", "K083269", "K031922", "K081341", "K070197", "K113196", "K000313", "K984260", "K120617", "K132030", "K843500", "K901391", "K021094", "K102925", "K082356", 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