{ "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": "2026-07-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Northfield", "state": "IL", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "96510", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "address_2": "", "postal_code": "60093-2753", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.", "recall_number": "Z-1597-2025", "product_description": "Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914", "product_quantity": "9216 units", "reason_for_recall": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.", "recall_initiation_date": "20250303", "center_classification_date": "20250417", "report_date": "20250423", "code_info": "1) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24IBE758; 2) DYNJ66514, UDI-DI: 10193489359282(each), 40193489359283(case), Lot Number: 24IBE817; 3) DYNJ67775A, UDI-DI: 10193489996258(each), 40193489996259(case), Lot Number: 24IBG346; 4) DYNJ83158, UDI-DI: 10195327236885(each), 40195327236886(case), Lot Number: 24IBG449; 5) DYNJ0634878I, UDI-DI: 10195327694500(each), 40195327694501(case), Lot Number: 24IBG548; 6) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24IBG570; 7) DYNJ44525C, UDI-DI: 10193489232042(each), 40193489232043(case), Lot Number: 24IBG608; 8) DYNJ44391K, UDI-DI: 10195327457648(each), 40195327457649(case), Lot Number: 24IBG848; 9) DYNJ49300D, UDI-DI: 10193489297287(each), 40193489297288(case), Lot Number: 24IBH734; 10) DYNJ61555B, UDI-DI: 10195327608101(each), 40195327608102(case), Lot Number: 24IBH769; 11) DYNJ57287A, UDI-DI: 10193489854152(each), 40193489854153(case), Lot Number: 24IBH959; 12) DYNJ36720F, UDI-DI: 10198459079306(each), 40198459079307(case), Lot Number: 24IBQ081; 13) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24IBQ933; 14) DYNJ36516, UDI-DI: 10884389544112(each), 40884389544113(case), Lot Number: 24IBR105; 15) DYNJ59502B, UDI-DI: 10193489372939(each), 40193489372930(case), Lot Number: 24IBR121; 16) DYNJ80790, UDI-DI: 10195327079482(each), 40195327079483(case), Lot Number: 24IBR337; 17) DYNJ57583, UDI-DI: 10889942755332(each), 40889942755333(case), Lot Number: 24IBR873; 18) DYNJ84876, UDI-DI: 10195327431778(each), 40195327431779(case), Lot Number: 24IBR895; 19) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24IBS352; 20) DYNJ908452C, UDI-DI: 10195327610937(each), 40195327610938(case), Lot Number: 24JBD799; 21) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 24JBF130; 22) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24JBK654; 23) DYNJ905762, UDI-DI: 10193489507966(each), 40193489507967(case), Lot Number: 24JBK682; 24) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBK897; 25) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24JBM367; 26) DYNJ59447A, UDI-DI: 10193489707663(each), 40193489707664(case), Lot Number: 24JBM926; 27) DYNJ26441R, UDI-DI: 10198459085888(each), 40198459085889(case), Lot Number: 24JBN335; 28) DYNJ58408A, UDI-DI: 10889942969029(each), 40889942969020(case), Lot Number: 24JBN611; 29) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24JBN781; 30) DYNJ61196A, UDI-DI: 10195327604240(each), 40195327604241(case), Lot Number: 24JBN797; 31) DYNJ66178D, UDI-DI: 10198459100307(each), 40198459100308(case), Lot Number: 24JBN811; 32) DYNJ37551A, UDI-DI: 10888277585720(each), 40888277585721(case), Lot Number: 24JBT022; 33) DYNJ68872F, UDI-DI: 10198459079269(each), 40198459079260(case), Lot Number: 24JBT065; 34) DYNJ50301C, UDI-DI: 10198459052330(each), 40198459052331(case), Lot Number: 24JBT456; 35) DYNJ40498B, UDI-DI: 10193489806779(each), 40193489806770(case), Lot Number: 24JBV199; 36) DYNJ46869A, UDI-DI: 10198459069949(each), 40198459069940(case), Lot Number: 24JBV309; 37) DYNJ58727D, UDI-DI: 10198459048425(each), 40198459048426(case), Lot Number: 24JBV608; 38) DYNJ45171C, UDI-DI: 10889942485260(each), 40889942485261(case), Lot Number: 24JBV814; 39) DYNJ56543J, UDI-DI: 10195327453602(each), 40195327453603(case), Lot Number: 24JBW129; 40) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24JBW183; 41) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24JBW623; 42) DYNJ40139D, UDI-DI: 10195327663506(each), 40195327663507(case), Lot Number: 24JBX313; 43) DYNJ32099A, UDI-DI: 10195327610890(each), 40195327610891(case), Lot Number: 24JBY276; 44) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBY278; 45) DYNJ53573A, UDI-DI: 10193489201635(each), 40193489201636(case), Lot Number: 24JBY404; 46) DYNJCH908, UDI-DI: 10193489393347(each), 40193489393348(case), Lot Number: 24KBA907; 47) DYNJ47481F, UDI-DI: 10195327067335(each), 40195327067336(case), Lot Number: 24KBB421; 48) DYNJ81479A, UDI-DI: 10195327378370(each), 40195327378371(case), Lot Number: 24KBB455; 49) DYNJ22357K, UDI-DI: 10193489926736(each), 40193489926737(case), Lot Number: 24KBB793; 50) DYNJ39317B, UDI-DI: 10889942775729(each), 40889942775720(case), Lot Number: 24KBC590; 51) DYNJ54321D, UDI-DI: 10195327679323(each), 40195327679324(case), Lot Number: 24KBC663; 52) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24KBC754; 53) DYNJ42451B, UDI-DI: 10193489740318(each), 40193489740319(case), Lot Number: 24KBC910; 54) DYNJ53348C, UDI-DI: 10195327453565(each), 40195327453566(case), Lot Number: 24KBD155; 55) DYNJ58596B, UDI-DI: 10195327635947(each), 40195327635948(case), Lot Number: 24KBD243; 56) DYNJ56262, UDI-DI: 10889942624331(each), 40889942624332(case), Lot Number: 24KBD661; 57) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24KBE334; 58) DYNJ68417C, UDI-DI: 10195327341633(each), 40195327341634(case), Lot Number: 24KBE396; 59) DYNJ48595, UDI-DI: 10888277915183(each), 40888277915184(case), Lot Number: 24KBE590; 60) DYNJ52611, UDI-DI: 10889942300853(each), 40889942300854(case), Lot Number: 24KBF355; 61) DYNJ81897B, UDI-DI: 10198459155710(each), 40198459155711(case), Lot Number: 24KBF577; 62) DYNJ43390A, UDI-DI: 10889942670321(each), 40889942670322(case), Lot Number: 24KBG019; 63) DYNJ34728D, UDI-DI: 10198459061851(each), 40198459061852(case), Lot Number: 24KBG035; 64) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24KBG072; 65) DYNJ41771C, UDI-DI: 10889942599189(each), 40889942599180(case), Lot Number: 24KBG178; 66) DYNJ68679B, UDI-DI: 10195327129095(each), 40195327129096(case), Lot Number: 24KBG186; 67) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24KBG371; 68) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24KBG399; 69) DYNJ83603, UDI-DI: 10195327284886(each), 40195327284887(case), Lot Number: 24KBG953; 70) DYNJ32247, UDI-DI: 10884389203873(each), 40884389203874(case), Lot Number: 24KBG965; 71) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24KBG993; 72) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24KBG996; 73) DYNJ25600L, UDI-DI: 10889942686247(each), 40889942686248(case), Lot Number: 24KBH226; 74) DYNJ38978C, UDI-DI: 10195327583590(each), 40195327583591(case), Lot Number: 24KBH242; 75) DYNJ50870D, UDI-DI: 10195327165666(each), 40195327165667(case), Lot Number: 24KBH280; 76) DYNJS0702, UDI-DI: 10080196798728(each), 40080196798729(case), Lot Number: 24KBI176; 77) DYNJ902836F, UDI-DI: 10198459002816(each), 40198459002817(case), Lot Number: 24KBI638; 78) DYNJ66039B, UDI-DI: 10195327151997(each), 40195327151998(case), Lot Number: 24KBL783; 79) DYNJ907844D, UDI-DI: 10195327387334(each), 40195327387335(case), Lot Number: 24KBP945; 80) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24LBA080", "more_code_info": "" } ] }