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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1602-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Refer to RES",
  "description": "FDA recall Z-1602-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Refer to RES (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1602-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Refer to RES",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1602-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1602-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Refer to RES",
      "text": "The FDA logged enforcement record Z-1602-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Refer to RES — reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-03-03. Affected lots/codes: 1) DYNJHTLD02A, UDI-DI: 10193489303360(each), 40193489303361(case), Lot Number: 24IBE784; 2) DYNJ50017B, UDI-DI: 10889942851126(each), 40889942851127(case), Lot Number: 24IBE809; 3) DYNJ68242C, UDI-DI: 10198459091568(each), 40198459091569(case), Lot Number: 24IBF050; 4) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24IBF241; 5) DYNJ42691, UDI-DI: 10888277003507(each), 40888277003508(case), Lot Number: 24IBF320; 6) DYNJ43775C, UDI-DI: 10889942763191(each), 40889942763192(case), Lot Number: 24IBF620; 7) DYNJ54078A, UDI-DI: 10193489528633(each), 40193489528634(case), Lot Number: 24IBF640; 8) DYNJ39493B, UDI-DI: 10889942669998(each), 40889942669999(case), Lot Number: 24IBG032; 9) DYNJ0101397O, UDI-DI: 10195327661663(each), 40195327661664(case), Lot Number: 24IBG201; 10) DYNJ28408J, UDI-DI: 10195327279684(each), 40195327279685(case), Lot Number: 24IBG536; 11) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24IBG574; 12) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24IBG595; 13) DYNJ44532D, UDI-DI: 10195327463700(each), 40195327463701(case), Lot Number: 24IBG706; 14) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBG871; 15) DYNJ63703B, UDI-DI: 10193489883466(each), 40193489883467(case), Lot Number: 24IBH017; 16) DYNJ59621A, UDI-DI: 10193489685374(each), 40193489685375(case), Lot Number: 24IBH300; 17) DYNJ37733B, UDI-DI: 10889942775712(each), 40889942775713(case), Lot Number: 24IBH634; 18) DYKE1321B, UDI-DI: 10193489532890(each), 40193489532891(case), Lot Number: 24IBH701; 19) DYNJ24860G, UDI-DI: 10889942361618(each), 40889942361619(case), Lot Number: 24IBH843; 20) DYNJ81648, UDI-DI: 10195327130640(each), 40195327130641(case), Lot Number: 24IBH845; 21) DYNJ84619, UDI-DI: 10195327386252(each), 40195327386253(case), Lot Number: 24IBI031; 22) DYNJHTLD02A, UDI-DI: 10193489303360(each), 40193489303361(case), Lot Number: 24IBP627; 23) DYNJ69017, UDI-DI: 10193489878158(each), 40193489878159(case), Lot Number: 24IBP905; 24) DYNJ42913A, UDI-DI: 10195327080600(each), 40195327080601(case), Lot Number: 24IBQ345; 25) DYNJCHCY01A, UDI-DI: 10888277551664(each), 40888277551665(case), Lot Number: 24IBQ381; 26) DYNJ62614A, UDI-DI: 10193489445466(each), 40193489445467(case), Lot Number: 24IBQ618; 27) DYKL1252B, UDI-DI: 10889942440016(each), 40889942440017(case), Lot Number: 24IBQ716; 28) DYNJ54307A, UDI-DI: 10195327327378(each), 40195327327379(case), Lot Number: 24IBQ767; 29) DYNJ32910A, UDI-DI: 10195327279264(each), 40195327279265(case), Lot Number: 24IBR140; 30) DYNJ50747, UDI-DI: 10889942020577(each), 40889942020578(case), Lot Number: 24IBR572; 31) DYNJ83381A, UDI-DI: 10195327366094(each), 40195327366095(case), Lot Number: 24IBR622; 32) DYNJHS0525C, UDI-DI: 10195327599638(each), 40195327599639(case), Lot Number: 24IBR899; 33) DYNJ50581, UDI-DI: 10889942008445(each), 40889942008446(case), Lot Number: 24IBR902; 34) DYNJ59094, UDI-DI: 10889942933501(each), 40889942933502(case), Lot Number: 24IBS361; 35) DYNJ84440, UDI-DI: 10195327365127(each), 40195327365128(case), Lot Number: 24IBS371; 36) DYNJ51611A, UDI-DI: 10889942453849(each), 40889942453840(case), Lot Number: 24IBS387; 37) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24IBS836; 38) DYNJ60191A, UDI-DI: 10193489204742(each), 40193489204743(case), Lot Number: 24IBU433; 39) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBV594; 40) DYNJ44962K, UDI-DI: 10198459045462(each), 40198459045463(case), Lot Number: 24JBA280; 41) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBA828; 42) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24JBA985; 43) DYNJ60802C, UDI-DI: 10195327404666(each), 40195327404667(case), Lot Number: 24JBF137; 44) DYNJ903254A, UDI-DI: 10889942632428(each), 40889942632429(case), Lot Number: 24JBK752; 45) DYNJ66251, UDI-DI: 10193489324778(each), 40193489324779(case), Lot Number: 24JBL345; 46) DYNJ52109, UDI-DI: 10889942239825(each), 40889942239826(case), Lot Number: 24JBL351; 47) DYNJ83154, UDI-DI: 10195327236847(each), 40195327236848(case), Lot Number: 24JBL827; 48) DYNJ40595A, UDI-DI: 10889942818648(each), 40889942818649(case), Lot Number: 24JBM390; 49) DYNJ48101C, UDI-DI: 10193489712520(each), 40193489712521(case), Lot Number: 24JBM496; 50) DYNJ62295B, UDI-DI: 10195327209933(each), 40195327209934(case), Lot Number: 24JBM500; 51) DYNJ33949G, UDI-DI: 10889942682515(each), 40889942682516(case), Lot Number: 24JBM602; 52) DYNJ34948C, UDI-DI: 10198459130076(each), 40198459130077(case), Lot Number: 24JBM855; 53) DYNJ39374B, UDI-DI: 10889942670871(each), 40889942670872(case), Lot Number: 24JBM858; 54) DYNJ41860B, UDI-DI: 10193489662634(each), 40193489662635(case), Lot Number: 24JBM890; 55) DYNJ66255, UDI-DI: 10193489324983(each), 40193489324984(case), Lot Number: 24JBM944; 56) DYNJ62348C, UDI-DI: 10195327538569(each), 40195327538560(case), Lot Number: 24JBN288; 57) DYNJ52891A, UDI-DI: 10889942819805(each), 40889942819806(case), Lot Number: 24JBN389; 58) DYNJ84784A, UDI-DI: 10195327447922(each), 40195327447923(case), Lot Number: 24JBN412; 59) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24JBN423; 60) DYNJ37145F, UDI-DI: 10195327467692(each), 40195327467693(case), Lot Number: 24JBN425; 61) DYNJ85241, UDI-DI: 10195327482657(each), 40195327482658(case), Lot Number: 24JBO099; 62) DYNJ52921B, UDI-DI: 10889942739240(each), 40889942739241(case), Lot Number: 24JBO261; 63) DYNJ82242, UDI-DI: 10195327181420(each), 40195327181421(case), Lot Number: 24JBO566; 64) CDS984266J, UDI-DI: 10193489862386(each), 40193489862387(case), Lot Number: 24JBO721; 65) DYNJ24478G, UDI-DI: 10193489866599(each), 40193489866590(case), Lot Number: 24JBR846; 66) DYNJ54741A, UDI-DI: 10889942921164(each), 40889942921165(case), Lot Number: 24JBT042; 67) DYNJ83931, UDI-DI: 10195327315351(each), 40195327315352(case), Lot Number: 24JBT083; 68) DYNJ57965B, UDI-DI: 10195327390037(each), 40195327390038(case), Lot Number: 24JBT485; 69) DYNJ67974, UDI-DI: 10193489462319(each), 40193489462310(case), Lot Number: 24JBT495; 70) DYNJ62128A, UDI-DI: 10193489449877(each), 40193489449878(case), Lot Number: 24JBT723; 71) DYNJ81969C, UDI-DI: 10198459003592(each), 40198459003593(case), Lot Number: 24JBT793; 72) DYNJ69017, UDI-DI: 10193489878158(each), 40193489878159(case), Lot Number: 24JBT855; 73) DYNJ48102C, UDI-DI: 10193489712537(each), 40193489712538(case), Lot Number: 24JBT937; 74) DYNJ43790, UDI-DI: 10888277068711(each), 40888277068712(case), Lot Number: 24JBT972; 75) SYNJ10266A, UDI-DI: 10193489785111(each), 40193489785112(case), Lot Number: 24JBU049; 76) DYNJ50747, UDI-DI: 10889942020577(each), 40889942020578(case), Lot Number: 24JBU066; 77) DYNJ44745B, UDI-DI: 10193489225693(each), 40193489225694(case), Lot Number: 24JBU107; 78) DYNJ49508A, UDI-DI: 10193489704013(each), 40193489704014(case), Lot Number: 24JBU167; 79) DYNJ49255B, UDI-DI: 10198459165023(each), 40198459165024(case), Lot Number: 24JBU462; 80) DYNJ39064, UDI-DI: 10884389736838(each), 40884389736839(case), Lot Number: 24JBU474; 81) DYNJ65869, UDI-DI: 10193489304039(each), 40193489304030(case), Lot Number: 24JBV140; 82) DYNJ46786G, UDI-DI: 10193489204353(each), 40193489204354(case), Lot Number: 24JBV421; 83) DYNJ35732D, UDI-DI: 10889942140701(each), 40889942140702(case), Lot Number: 24JBV518; 84) DYNJ68390C, UDI-DI: 10195327341671(each), 40195327341672(case), Lot Number: 24JBV597; 85) DYNJ48474G, UDI-DI: 10888277767867(each), 40888277767868(case), Lot Number: 24JBV613; 86) DYNJ54609C, UDI-DI: 10198459046452(each), 40198459046453(case), Lot Number: 24JBV668; 87) DYNJ63703B, UDI-DI: 10193489883466(each), 40193489883467(case), Lot Number: 24JBV847; 88) DYNJ84831A, UDI-DI: 10198459136962(each), 40198459136963(case), Lot Number: 24JBV896; 89) DYNJ61473, UDI-DI: 10193489572315(each), 40193489572316(case), Lot Number: 24JBW127; 90) DYNJ61467, UDI-DI: 10193489572261(each), 40193489572262(case), Lot Number: 24JBW164; 91) DYNJ59370B, UDI-DI: 10198459165801(each), 40198459165802(case), Lot Number: 24JBW172; 92) DYNJ36096F, UDI-DI: 10195327654085(each), 40195327654086(case), Lot Number: 24JBW181; 93) DYNJ37318F, UDI-DI: 10193489672756(each), 40193489672757(case), Lot Number: 24JBW188; 94) DYNJ55425B, UDI-DI: 10193489297416(each), 40193489297417(case), Lot Number: 24JBW462; 95) DYNJ51016, UDI-DI: 10889942111213(each), 40889942111214(case), Lot Number: 24JBW498; 96) DYNJ19845K, UDI-DI: 10888277851030(each), 40888277851031(case), Lot Number: 24JBX126; 97) PHS419284011D, UDI-DI: 10198459132124(each), 40198459132125(case), Lot Number: 24JBX226; 98) DYKL1252B, UDI-DI: 10889942440016(each), 40889942440017(case), Lot Number: 24JBX632; 99) DYNJ45044D, UDI-DI: 10193489235500(each), 40193489235501(case), Lot Number: 24JBX706; 100) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24JBX711; 101) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBX748; 102) DYNJ58401A, UDI-DI: 10889942969586(each), 40889942969587(case), Lot Number: 24JBX751; 103) DYNJ55206A, UDI-DI: 10193489727067(each), 40193489727068(case), Lot Number: 24JBX991; 104) DYNJ68761A, UDI-DI: 10198459031847(each), 40198459031848(case), Lot Number: 24JBY188; 105) DYNJ44858J, UDI-DI: 10195327127336(each), 40195327127337(case), Lot Number: 24JBY279; 106) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBA223; 107) DYNJ44037D, UDI-DI: 10195327038748(each), 40195327038749(case), Lot Number: 24KBA571; 108) DYNJ61350, UDI-DI: 10193489560992(each), 40193489560993(case), Lot Number: 24KBA573; 109) DYNJ0373855R, UDI-DI: 10198459062193(each), 40198459062194(case), Lot Number: 24KBA650; 110) DYNJ57039B, UDI-DI: 10193489353433(each), 40193489353434(case), Lot Number: 24KBA692; 111) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB141; 112) DYNJ36951A, UDI-DI: 10884389666630(each), 40884389666631(case), Lot Number: 24KBB214; 113) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24KBB217; 114) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB400; 115) DYNJ41724, UDI-DI: 10888277021488(each), 40888277021489(case), Lot Number: 24KBB417; 116) DYNJ60250A, UDI-DI: 10198459015274(each), 40198459015275(case), Lot Number: 24KBB762; 117) DYNJ56862D, UDI-DI: 10195327642969(each), 40195327642960(case), Lot Number: 24KBB799; 118) DYNJ65800, UDI-DI: 10193489291278(each), 40193489291279(case), Lot Number: 24KBB811; 119) DYNJ61287, UDI-DI: 10193489554854(each), 40193489554855(case), Lot Number: 24KBC474; 120) DYNJ69943C, UDI-DI: 10198459057359(each), 40198459057350(case), Lot Number: 24KBC517; 121) DYNJ16105F, UDI-DI: 10889942364169(each), 40889942364160(case), Lot Number: 24KBC556; 122) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24KBC559; 123) DYNJ37032F, UDI-DI: 10193489637175(each), 40193489637176(case), Lot Number: 24KBC579; 124) DYNJ39496A, UDI-DI: 10889942670345(each), 40889942670346(case), Lot Number: 24KBC591; 125) DYNJ60396, UDI-DI: 10193489500301(each), 40193489500302(case), Lot Number: 24KBC689; 126) DYNJ61364A, UDI-DI: 10193489722116(each), 40193489722117(case), Lot Number: 24KBC706; 127) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBC729; 128) DYNJ67867C, UDI-DI: 10198459158490(each), 40198459158491(case), Lot Number: 24KBC757; 129) DYNJ81788, UDI-DI: 10195327143114(each), 40195327143115(case), Lot Number: 24KBC802; 130) DYNJ86504, UDI-DI: 10195327643690(each), 40195327643691(case), Lot Number: 24KBC868; 131) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24KBC906; 132) DYNJ43428, UDI-DI: 10888277051263(each), 40888277051264(case), Lot Number: 24KBD224; 133) DYNJ41941D, UDI-DI: 10193489753707(each), 40193489753708(case), Lot Number: 24KBD843; 134) DYNJ44028A, UDI-DI: 10889942135691(each), 40889942135692(case), Lot Number: 24KBD852; 135) DYNJ51865A, UDI-DI: 10889942322633(each), 40889942322634(case), Lot Number: 24KBD881; 136) DYNJ53122B, UDI-DI: 10193489321227(each), 40193489321228(case), Lot Number: 24KBD891; 137) DYNJ54064B, UDI-DI: 10198459155413(each), 40198459155414(case), Lot Number: 24KBD896; 138) DYNJ58341, UDI-DI: 10889942842438(each), 40889942842439(case), Lot Number: 24KBE274; 139) DYNJ48017F, UDI-DI: 10198459129049(each), 40198459129040(case), Lot Number: 24KBE389; 140) DYNJ56857G, UDI-DI: 10195327614669(each), 40195327614660(case), Lot Number: 24KBE656; 141) DYNJ60279C, UDI-DI: 10195327441760(each), 40195327441761(case), Lot Number: 24KBF085; 142) DYNJ33451L, UDI-DI: 10198459169687(each), 40198459169688(case), Lot Number: 24KBF135; 143) DYNJ32910A, UDI-DI: 10195327279264(each), 40195327279265(case), Lot Number: 24KBF321; 144) DYNJ40110, UDI-DI: 10884389837849(each), 40884389837840(case), Lot Number: 24KBF330; 145) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBF361; 146) DYNJ62502, UDI-DI: 10193489664874(each), 40193489664875(case), Lot Number: 24KBG152; 147) DYNJ15962I, UDI-DI: 10889942364138(each), 40889942364139(case), Lot Number: 24KBG286; 148) DYNJ51162, UDI-DI: 10889942141821(each), 40889942141822(case), Lot Number: 24KBG849; 149) DYNJ23098K, UDI-DI: 10193489213331(each), 40193489213332(case), Lot Number: 24KBG919; 150) DYNJ54307A, UDI-DI: 10195327327378(each), 40195327327379(case), Lot Number: 24KBG970; 151) DYNDH1606, UDI-DI: 10193489844771(each), 40193489844772(case), Lot Number: 24KBH207; 152) DYNJ40391, UDI-DI: 10884389864531(each), 40884389864532(case), Lot Number: 24KBH247; 153) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBH291; 154) DYNJ58419B, UDI-DI: 10193489915938(each), 40193489915939(case), Lot Number: 24KBH312; 155) DYNJ69967B, UDI-DI: 10198459070532(each), 40198459070533(case), Lot Number: 24KBH377; 156) DYNJ68519A, UDI-DI: 10193489916041(each), 40193489916042(case), Lot Number: 24KBH523; 157) DYNJ0858275B, UDI-DI: 10889942137251(each), 40889942137252(case), Lot Number: 24KBH791; 158) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24KBH845; 159) DYNJ85345A, UDI-DI: 10198459111549(each), 40198459111540(case), Lot Number: 24KBI150; 160) DYNJ55866C, UDI-DI: 10198459126093(each), 40198459126094(case), Lot Number: 24KBK546; 161) DYNJ81892D, UDI-DI: 10198459048104(each), 40198459048105(case), Lot Number: 24KBM589; 162) DYNJ909278A, UDI-DI: 10195327605247(each), 40195327605248(case), Lot Number: 24KBP718; 163) DYNJ903255A, UDI-DI: 10889942632435(each), 40889942632436(case), Lot Number: 24KBQ385; 164) CDS980470D, UDI-DI: 10889942965045(each), 40889942965046(case), Lot Number: 24KBQ708; 165) CDS982696K, UDI-DI: 10193489441406(each), 40193489441407(case), Lot Number: 24KBR961; 166) DYNJ907550B, UDI-DI: 10195327076320(each), 40195327076321(case), Lot Number: 24LBD358; 167) CDS840343K, UDI-DI: 10888277865693(each), 40888277865694(case), Lot Number: 24LBD743; 168) CDS983099K, UDI-DI: 10198459020377(each), 40198459020378(case), Lot Number: 24LBE132; 169) DYNJ904853A, UDI-DI: 10193489630978(each), 40193489630979(case), Lot Number: 24LBJ828; 170) DYNJ901896C, UDI-DI: 10193489553789(each), 40193489553780(case), Lot Number: 24LBL495. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1602-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1602-2025&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1602-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1602-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1602-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1602-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1602-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1602-2025",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1602-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-03-03",
            "Status": "recorded"
          }
        },
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36) DYNJ51611A, UDI-DI: 10889942453849(each), 40889942453840(case), Lot Number: 24IBS387; 37) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24IBS836; 38) DYNJ60191A, UDI-DI: 10193489204742(each), 40193489204743(case), Lot Number: 24IBU433; 39) DYNJ65996C, UDI-DI: 10195327621698(each), 40195327621699(case), Lot Number: 24IBV594; 40) DYNJ44962K, UDI-DI: 10198459045462(each), 40198459045463(case), Lot Number: 24JBA280; 41) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBA828; 42) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24JBA985; 43) DYNJ60802C, UDI-DI: 10195327404666(each), 40195327404667(case), Lot Number: 24JBF137; 44) DYNJ903254A, UDI-DI: 10889942632428(each), 40889942632429(case), Lot Number: 24JBK752; 45) DYNJ66251, UDI-DI: 10193489324778(each), 40193489324779(case), Lot Number: 24JBL345; 46) DYNJ52109, UDI-DI: 10889942239825(each), 40889942239826(case), Lot Number: 24JBL351; 47) DYNJ83154, UDI-DI: 10195327236847(each), 40195327236848(case), Lot Number: 24JBL827; 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60) DYNJ37145F, UDI-DI: 10195327467692(each), 40195327467693(case), Lot Number: 24JBN425; 61) DYNJ85241, UDI-DI: 10195327482657(each), 40195327482658(case), Lot Number: 24JBO099; 62) DYNJ52921B, UDI-DI: 10889942739240(each), 40889942739241(case), Lot Number: 24JBO261; 63) DYNJ82242, UDI-DI: 10195327181420(each), 40195327181421(case), Lot Number: 24JBO566; 64) CDS984266J, UDI-DI: 10193489862386(each), 40193489862387(case), Lot Number: 24JBO721; 65) DYNJ24478G, UDI-DI: 10193489866599(each), 40193489866590(case), Lot Number: 24JBR846; 66) DYNJ54741A, UDI-DI: 10889942921164(each), 40889942921165(case), Lot Number: 24JBT042; 67) DYNJ83931, UDI-DI: 10195327315351(each), 40195327315352(case), Lot Number: 24JBT083; 68) DYNJ57965B, UDI-DI: 10195327390037(each), 40195327390038(case), Lot Number: 24JBT485; 69) DYNJ67974, UDI-DI: 10193489462319(each), 40193489462310(case), Lot Number: 24JBT495; 70) DYNJ62128A, UDI-DI: 10193489449877(each), 40193489449878(case), Lot Number: 24JBT723; 71) DYNJ81969C, UDI-DI: 10198459003592(each), 40198459003593(case), Lot Number: 24JBT793; 72) DYNJ69017, UDI-DI: 10193489878158(each), 40193489878159(case), Lot Number: 24JBT855; 73) DYNJ48102C, UDI-DI: 10193489712537(each), 40193489712538(case), Lot Number: 24JBT937; 74) DYNJ43790, UDI-DI: 10888277068711(each), 40888277068712(case), Lot Number: 24JBT972; 75) SYNJ10266A, UDI-DI: 10193489785111(each), 40193489785112(case), Lot Number: 24JBU049; 76) DYNJ50747, UDI-DI: 10889942020577(each), 40889942020578(case), Lot Number: 24JBU066; 77) DYNJ44745B, UDI-DI: 10193489225693(each), 40193489225694(case), Lot Number: 24JBU107; 78) DYNJ49508A, UDI-DI: 10193489704013(each), 40193489704014(case), Lot Number: 24JBU167; 79) DYNJ49255B, UDI-DI: 10198459165023(each), 40198459165024(case), Lot Number: 24JBU462; 80) DYNJ39064, UDI-DI: 10884389736838(each), 40884389736839(case), Lot Number: 24JBU474; 81) DYNJ65869, UDI-DI: 10193489304039(each), 40193489304030(case), Lot Number: 24JBV140; 82) DYNJ46786G, UDI-DI: 10193489204353(each), 40193489204354(case), Lot Number: 24JBV421; 83) DYNJ35732D, UDI-DI: 10889942140701(each), 40889942140702(case), Lot Number: 24JBV518; 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96) DYNJ19845K, UDI-DI: 10888277851030(each), 40888277851031(case), Lot Number: 24JBX126; 97) PHS419284011D, UDI-DI: 10198459132124(each), 40198459132125(case), Lot Number: 24JBX226; 98) DYKL1252B, UDI-DI: 10889942440016(each), 40889942440017(case), Lot Number: 24JBX632; 99) DYNJ45044D, UDI-DI: 10193489235500(each), 40193489235501(case), Lot Number: 24JBX706; 100) DYNJ45997C, UDI-DI: 10889942684366(each), 40889942684367(case), Lot Number: 24JBX711; 101) DYNJ57753, UDI-DI: 10889942774395(each), 40889942774396(case), Lot Number: 24JBX748; 102) DYNJ58401A, UDI-DI: 10889942969586(each), 40889942969587(case), Lot Number: 24JBX751; 103) DYNJ55206A, UDI-DI: 10193489727067(each), 40193489727068(case), Lot Number: 24JBX991; 104) DYNJ68761A, UDI-DI: 10198459031847(each), 40198459031848(case), Lot Number: 24JBY188; 105) DYNJ44858J, UDI-DI: 10195327127336(each), 40195327127337(case), Lot Number: 24JBY279; 106) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBA223; 107) DYNJ44037D, UDI-DI: 10195327038748(each), 40195327038749(case), Lot Number: 24KBA571; 108) DYNJ61350, UDI-DI: 10193489560992(each), 40193489560993(case), Lot Number: 24KBA573; 109) DYNJ0373855R, UDI-DI: 10198459062193(each), 40198459062194(case), Lot Number: 24KBA650; 110) DYNJ57039B, UDI-DI: 10193489353433(each), 40193489353434(case), Lot Number: 24KBA692; 111) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB141; 112) DYNJ36951A, UDI-DI: 10884389666630(each), 40884389666631(case), Lot Number: 24KBB214; 113) DYNJ56508G, UDI-DI: 10193489734133(each), 40193489734134(case), Lot Number: 24KBB217; 114) DYNJ30550F, UDI-DI: 10198459130946(each), 40198459130947(case), Lot Number: 24KBB400; 115) DYNJ41724, UDI-DI: 10888277021488(each), 40888277021489(case), Lot Number: 24KBB417; 116) DYNJ60250A, UDI-DI: 10198459015274(each), 40198459015275(case), Lot Number: 24KBB762; 117) DYNJ56862D, UDI-DI: 10195327642969(each), 40195327642960(case), Lot Number: 24KBB799; 118) DYNJ65800, UDI-DI: 10193489291278(each), 40193489291279(case), Lot Number: 24KBB811; 119) DYNJ61287, UDI-DI: 10193489554854(each), 40193489554855(case), Lot Number: 24KBC474; 120) DYNJ69943C, UDI-DI: 10198459057359(each), 40198459057350(case), Lot Number: 24KBC517; 121) DYNJ16105F, UDI-DI: 10889942364169(each), 40889942364160(case), Lot Number: 24KBC556; 122) DYNJ17504G, UDI-DI: 10195327224479(each), 40195327224470(case), Lot Number: 24KBC559; 123) DYNJ37032F, UDI-DI: 10193489637175(each), 40193489637176(case), Lot Number: 24KBC579; 124) DYNJ39496A, UDI-DI: 10889942670345(each), 40889942670346(case), Lot Number: 24KBC591; 125) DYNJ60396, UDI-DI: 10193489500301(each), 40193489500302(case), Lot Number: 24KBC689; 126) DYNJ61364A, UDI-DI: 10193489722116(each), 40193489722117(case), Lot Number: 24KBC706; 127) DYNJ64353A, UDI-DI: 10193489285871(each), 40193489285872(case), Lot Number: 24KBC729; 128) DYNJ67867C, UDI-DI: 10198459158490(each), 40198459158491(case), Lot Number: 24KBC757; 129) DYNJ81788, UDI-DI: 10195327143114(each), 40195327143115(case), Lot Number: 24KBC802; 130) DYNJ86504, UDI-DI: 10195327643690(each), 40195327643691(case), Lot Number: 24KBC868; 131) SYNJ10001B, UDI-DI: 10195327067977(each), 40195327067978(case), Lot Number: 24KBC906; 132) DYNJ43428, UDI-DI: 10888277051263(each), 40888277051264(case), Lot Number: 24KBD224; 133) DYNJ41941D, UDI-DI: 10193489753707(each), 40193489753708(case), Lot Number: 24KBD843; 134) DYNJ44028A, UDI-DI: 10889942135691(each), 40889942135692(case), Lot Number: 24KBD852; 135) DYNJ51865A, UDI-DI: 10889942322633(each), 40889942322634(case), Lot Number: 24KBD881; 136) DYNJ53122B, UDI-DI: 10193489321227(each), 40193489321228(case), Lot Number: 24KBD891; 137) DYNJ54064B, UDI-DI: 10198459155413(each), 40198459155414(case), Lot Number: 24KBD896; 138) DYNJ58341, UDI-DI: 10889942842438(each), 40889942842439(case), Lot Number: 24KBE274; 139) DYNJ48017F, UDI-DI: 10198459129049(each), 40198459129040(case), Lot Number: 24KBE389; 140) DYNJ56857G, UDI-DI: 10195327614669(each), 40195327614660(case), Lot Number: 24KBE656; 141) DYNJ60279C, UDI-DI: 10195327441760(each), 40195327441761(case), Lot Number: 24KBF085; 142) DYNJ33451L, UDI-DI: 10198459169687(each), 40198459169688(case), Lot Number: 24KBF135; 143) DYNJ32910A, UDI-DI: 10195327279264(each), 40195327279265(case), Lot Number: 24KBF321; 144) DYNJ40110, UDI-DI: 10884389837849(each), 40884389837840(case), Lot Number: 24KBF330; 145) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBF361; 146) DYNJ62502, UDI-DI: 10193489664874(each), 40193489664875(case), Lot Number: 24KBG152; 147) DYNJ15962I, UDI-DI: 10889942364138(each), 40889942364139(case), Lot Number: 24KBG286; 148) DYNJ51162, UDI-DI: 10889942141821(each), 40889942141822(case), Lot Number: 24KBG849; 149) DYNJ23098K, UDI-DI: 10193489213331(each), 40193489213332(case), Lot Number: 24KBG919; 150) DYNJ54307A, UDI-DI: 10195327327378(each), 40195327327379(case), Lot Number: 24KBG970; 151) DYNDH1606, UDI-DI: 10193489844771(each), 40193489844772(case), Lot Number: 24KBH207; 152) DYNJ40391, UDI-DI: 10884389864531(each), 40884389864532(case), Lot Number: 24KBH247; 153) DYNJ54033, UDI-DI: 10889942457588(each), 40889942457589(case), Lot Number: 24KBH291; 154) DYNJ58419B, UDI-DI: 10193489915938(each), 40193489915939(case), Lot Number: 24KBH312; 155) DYNJ69967B, UDI-DI: 10198459070532(each), 40198459070533(case), Lot Number: 24KBH377; 156) DYNJ68519A, UDI-DI: 10193489916041(each), 40193489916042(case), Lot Number: 24KBH523; 157) DYNJ0858275B, UDI-DI: 10889942137251(each), 40889942137252(case), Lot Number: 24KBH791; 158) DYNJ52804A, UDI-DI: 10888277785328(each), 40888277785329(case), Lot Number: 24KBH845; 159) DYNJ85345A, UDI-DI: 10198459111549(each), 40198459111540(case), Lot Number: 24KBI150; 160) DYNJ55866C, UDI-DI: 10198459126093(each), 40198459126094(case), Lot Number: 24KBK546; 161) DYNJ81892D, UDI-DI: 10198459048104(each), 40198459048105(case), Lot Number: 24KBM589; 162) DYNJ909278A, UDI-DI: 10195327605247(each), 40195327605248(case), Lot Number: 24KBP718; 163) DYNJ903255A, UDI-DI: 10889942632435(each), 40889942632436(case), Lot Number: 24KBQ385; 164) CDS980470D, UDI-DI: 10889942965045(each), 40889942965046(case), Lot Number: 24KBQ708; 165) CDS982696K, UDI-DI: 10193489441406(each), 40193489441407(case), Lot Number: 24KBR961; 166) DYNJ907550B, UDI-DI: 10195327076320(each), 40195327076321(case), Lot Number: 24LBD358; 167) CDS840343K, UDI-DI: 10888277865693(each), 40888277865694(case), Lot Number: 24LBD743; 168) CDS983099K, UDI-DI: 10198459020377(each), 40198459020378(case), Lot Number: 24LBE132; 169) DYNJ904853A, UDI-DI: 10193489630978(each), 40193489630979(case), Lot Number: 24LBJ828; 170) DYNJ901896C, UDI-DI: 10193489553789(each), 40193489553780(case), Lot Number: 24LBL495",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}