{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1530-2025.jsonld", "@type": "schema:Dataset", "name": "Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93\", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS", "description": "FDA recall Z-1530-2025 — MEDLINE INDUSTRIES, LP - Northfield is recalling Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93\", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS (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.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "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": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1530-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93\", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS", "manufacturer": { "@type": "schema:Organization", "name": "MEDLINE INDUSTRIES, LP - Northfield" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1530-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1530-2025: MEDLINE INDUSTRIES, LP - Northfield is recalling Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93\", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS", "text": "The FDA logged enforcement record Z-1530-2025: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93\", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOLLOID,FINGER&TOE,8CT 5) Model Number: RA0353818V1, BANDAGE,BLISTER, RITEAID,6EA/BX, 24BX/CS — reason: There is a potential for the sterility of the device to be compromised.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-19. Affected lots/codes: 1) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10315040001; 2) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317020005; 3) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317030004; 4) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317120001; 5) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318050003; 6) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318070002; 7) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318080003; 8) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319010004; 9) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319050004; 10) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319060001; 11) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110002; 12) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110004; 13) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320030005; 14) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320050002; 15) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080001; 16) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080002; 17) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100001; 18) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100002; 19) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321030001; 20) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321040007; 21) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050003; 22) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050004; 23) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321090002; 24) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321110002; 25) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322070004; 26) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322080003; 27) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030001; 28) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030003; 29) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323070001; 30) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323080006; 31) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323090005; 32) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324010006; 33) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324040002; 34) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324070001; 35) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324090004; 36) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319020001; 37) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319050005; 38) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319080004; 39) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319100004; 40) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320030003; 41) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320080001; 42) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320090003; 43) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321010004; 44) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321020001; 45) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321030001; 46) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321040005; 47) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321050006; 48) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321070003; 49) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321080004; 50) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090005; 51) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090006; 52) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100001; 53) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100006; 54) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322020002; 55) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322090003; 56) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322110002; 57) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323030003; 58) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323060001; 59) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323080001; 60) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323090002; 61) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323110003; 62) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324020001; 63) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319020001; 64) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319050005; 65) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319080003; 66) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319120004; 67) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320040002; 68) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320070003; 69) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320090001; 70) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010001; 71) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010004; 72) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321020001; 73) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030001; 74) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030004; 75) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321050006; 76) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070003; 77) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070004; 78) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321080005; 79) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100001; 80) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100005; 81) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322010001; 82) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322020002; 83) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322030001; 84) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322100001; 85) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322120002; 86) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323030003; 87) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323040001; 88) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323080001; 89) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323100003; 90) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324020002; 91) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319020001; 92) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319050003; 93) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319070003; 94) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319080001; 95) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319110001; 96) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319120001; 97) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070001; 98) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070003; 99) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320090004; 100) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320110001; 101) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320120004; 102) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010002; 103) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010004; 104) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321020001; 105) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321030001; 106) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070003; 107) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070004; 108) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321080005; 109) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090001; 110) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090007; 111) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100001; 112) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100002; 113) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100005; 114) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322020002; 115) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080003; 116) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080004; 117) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090001; 118) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090002; 119) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322100001; 120) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322120002; 121) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323010002; 122) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323030004; 123) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323060001; 124) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323070003; 125) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323080006; 126) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323090005; 127) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323100003; 128) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010001; 129) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010006; 130) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324030004; 131) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323080007; 132) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090004; 133) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090005; 134) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323100002; 135) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10324010006;. 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-1530-2025&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-1530-2025&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-1530-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1530-2025 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-1530-2025&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-1530-2025&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-1530-2025/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": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1530-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1530-2025", "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 the sterility of the device to be compromised.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-02-19", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "1) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10315040001; 2) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317020005; 3) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317030004; 4) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10317120001; 5) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318050003; 6) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318070002; 7) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10318080003; 8) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319010004; 9) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319050004; 10) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319060001; 11) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110002; 12) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10319110004; 13) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320030005; 14) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320050002; 15) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080001; 16) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320080002; 17) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100001; 18) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10320100002; 19) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321030001; 20) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321040007; 21) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050003; 22) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321050004; 23) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321090002; 24) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10321110002; 25) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322070004; 26) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10322080003; 27) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030001; 28) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323030003; 29) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323070001; 30) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323080006; 31) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10323090005; 32) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324010006; 33) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324040002; 34) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324070001; 35) CUR5103, UDI-DI: 00888277307400(each), 40888277307408(case), Lot Number: 10324090004; 36) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319020001; 37) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319050005; 38) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319080004; 39) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10319100004; 40) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320030003; 41) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320080001; 42) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10320090003; 43) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321010004; 44) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321020001; 45) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321030001; 46) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321040005; 47) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321050006; 48) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321070003; 49) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321080004; 50) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090005; 51) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321090006; 52) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100001; 53) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10321100006; 54) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322020002; 55) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322090003; 56) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10322110002; 57) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323030003; 58) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323060001; 59) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323080001; 60) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323090002; 61) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10323110003; 62) MJ18004, UDI-DI: 00708820656963(each), 20708820656967(case), Lot Number: 10324020001; 63) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319020001; 64) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319050005; 65) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319080003; 66) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10319120004; 67) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320040002; 68) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320070003; 69) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10320090001; 70) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010001; 71) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321010004; 72) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321020001; 73) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030001; 74) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321030004; 75) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321050006; 76) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070003; 77) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321070004; 78) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321080005; 79) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100001; 80) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10321100005; 81) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322010001; 82) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322020002; 83) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322030001; 84) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322100001; 85) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10322120002; 86) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323030003; 87) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323040001; 88) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323080001; 89) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10323100003; 90) MJ18005, UDI-DI: 00708820656970(each), 20708820656974(case), Lot Number: 10324020002; 91) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319020001; 92) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319050003; 93) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319070003; 94) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319080001; 95) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319110001; 96) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10319120001; 97) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070001; 98) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320070003; 99) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320090004; 100) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320110001; 101) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10320120004; 102) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010002; 103) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321010004; 104) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321020001; 105) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321030001; 106) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070003; 107) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321070004; 108) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321080005; 109) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090001; 110) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321090007; 111) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100001; 112) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100002; 113) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10321100005; 114) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322020002; 115) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080003; 116) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322080004; 117) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090001; 118) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322090002; 119) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322100001; 120) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10322120002; 121) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323010002; 122) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323030004; 123) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323060001; 124) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323070003; 125) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323080006; 126) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323090005; 127) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10323100003; 128) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010001; 129) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324010006; 130) MJ76126V1, UDI-DI: 00708820502734(each), 40708820502732(case), Lot Number: 10324030004; 131) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323080007; 132) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090004; 133) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323090005; 134) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10323100002; 135) RA0353818V1, UDI-DI: 00011822538183(each), 40011822538181(case), Lot Number: 10324010006;", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of: Bermuda, Canada, Panama, Singapore", "Status": "recorded" } } ] } ] }