{
  "@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-2094-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) PICC LINE TRAY, Model Number:00-401993O;   2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B;   3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C;   4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487;   5) PEDS PICC INSERTION TRAY, Model Number:CVI3650;   6) LINE ATTIRE KIT, Model Number:DYKM2170;   7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274;   8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C;   9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A;   10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C;   11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B;   12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D;   13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F;   14) PLACENTA KIT, Model Number:DYNDA2322B;   15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A;   16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B;   17) PICC LINE TRAY, Model Number:DYNJ40500A;   18) VENOUS ACCESS PACK, Model Number:DYNJ42694C;   19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B;   20) PICC LINE, Model Number:DYNJ55546D;   21) PICC TRAY, Model Number:DYNJ63199A;   22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB;   23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB;   24) VEIN PACK, Model Number:DYNJ84239;   25) NEXTON PACK, Model Number:DYNJ88152;   26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004",
  "description": "FDA recall Z-2094-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) PICC LINE TRAY, Model Number:00-401993O;   2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B;   3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C;   4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487;   5) PEDS PICC INSERTION TRAY, Model Number:CVI3650;   6) LINE ATTIRE KIT, Model Number:DYKM2170;   7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274;   8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C;   9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A;   10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C;   11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B;   12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D;   13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F;   14) PLACENTA KIT, Model Number:DYNDA2322B;   15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A;   16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B;   17) PICC LINE TRAY, Model Number:DYNJ40500A;   18) VENOUS ACCESS PACK, Model Number:DYNJ42694C;   19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B;   20) PICC LINE, Model Number:DYNJ55546D;   21) PICC TRAY, Model Number:DYNJ63199A;   22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB;   23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB;   24) VEIN PACK, Model Number:DYNJ84239;   25) NEXTON PACK, Model Number:DYNJ88152;   26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004 (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-2094-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) PICC LINE TRAY, Model Number:00-401993O;   2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B;   3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C;   4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487;   5) PEDS PICC INSERTION TRAY, Model Number:CVI3650;   6) LINE ATTIRE KIT, Model Number:DYKM2170;   7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274;   8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C;   9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A;   10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C;   11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B;   12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D;   13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F;   14) PLACENTA KIT, Model Number:DYNDA2322B;   15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A;   16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B;   17) PICC LINE TRAY, Model Number:DYNJ40500A;   18) VENOUS ACCESS PACK, Model Number:DYNJ42694C;   19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B;   20) PICC LINE, Model Number:DYNJ55546D;   21) PICC TRAY, Model Number:DYNJ63199A;   22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB;   23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB;   24) VEIN PACK, Model Number:DYNJ84239;   25) NEXTON PACK, Model Number:DYNJ88152;   26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2094-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2094-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) PICC LINE TRAY, Model Number:00-401993O;   2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B;   3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C;   4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487;   5) PEDS PICC INSERTION TRAY, Model Number:CVI3650;   6) LINE ATTIRE KIT, Model Number:DYKM2170;   7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274;   8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C;   9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A;   10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C;   11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B;   12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D;   13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F;   14) PLACENTA KIT, Model Number:DYNDA2322B;   15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A;   16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B;   17) PICC LINE TRAY, Model Number:DYNJ40500A;   18) VENOUS ACCESS PACK, Model Number:DYNJ42694C;   19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B;   20) PICC LINE, Model Number:DYNJ55546D;   21) PICC TRAY, Model Number:DYNJ63199A;   22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB;   23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB;   24) VEIN PACK, Model Number:DYNJ84239;   25) NEXTON PACK, Model Number:DYNJ88152;   26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004",
      "text": "The FDA logged enforcement record Z-2094-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) PICC LINE TRAY, Model Number:00-401993O;   2) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268B;   3) CODE CART ADULT 4 CENTRAL LINE, Model Number:ACC010268C;   4) TRAY 6 CENTRAL LINE A, Model Number:ACC010487;   5) PEDS PICC INSERTION TRAY, Model Number:CVI3650;   6) LINE ATTIRE KIT, Model Number:DYKM2170;   7) PK BNDL CENT LINE PROTECT KIT, Model Number:DYKM2274;   8) KIT SURG ONC LAP DIAG/PORT INS, Model Number:DYKMBNDL153C;   9) KIT SURG ONC INSERT CENT.VENOU, Model Number:DYKMBNDL43A;   10) KIT SURG ONC PORT INSERTION, Model Number:DYKMBNDL43C;   11) VEIN PROCEDURE KIT, Model Number:DYNDA2076B;   12) VEIN PROCEDURE KIT, Model Number:DYNDA2076D;   13) VEIN PROCEDURE KIT, Model Number:DYNDA2076F;   14) PLACENTA KIT, Model Number:DYNDA2322B;   15) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407A;   16) NICU CENTRAL LINE TRAY, Model Number:DYNDC2407B;   17) PICC LINE TRAY, Model Number:DYNJ40500A;   18) VENOUS ACCESS PACK, Model Number:DYNJ42694C;   19) AV FISTULA CREATION PACK-LF, Model Number:DYNJ53427B;   20) PICC LINE, Model Number:DYNJ55546D;   21) PICC TRAY, Model Number:DYNJ63199A;   22) PICC KIT 4F SL PL MAX BARRIER, Model Number:DYNJ70141MB;   23) PICC KIT 5F DL PL MB, Model Number:DYNJ70152MB;   24) VEIN PACK, Model Number:DYNJ84239;   25) NEXTON PACK, Model Number:DYNJ88152;   26) PICC INSERTION TRAY W/O CATH, Model Number:PICCNC0004 — reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-07. Affected lots/codes: 1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 57) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 58) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 59) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 60) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 61) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 23HMC992; 62) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24AMB024; 63) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24CMI922; 64) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24DMF048; 65) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24IMD214; 66) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25EMA699; 67) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 68) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 69) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23FBG757; 70) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23HBB480; 71) DYNJ42694C, UDI-DI: 10195327514334(each), 40195327514335(case), Lot Number: 24ABW686; 72) DYNJ53427B, UDI-DI: 10193489248227(each), 40193489248228(case), Lot Number: 20LDC151; 73) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22IBQ424; 74) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22LBG357; 75) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23BBB100; 76) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23CBT475; 77) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23GBK664; 78) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22BBP290; 79) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22IBO930; 80) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22JBN171; 81) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970; 82) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 25CBK996; 83) DYNJ70141MB, UDI-DI: 10889942722808(each), 40889942722809(case), Lot Number: 21ADA546; 84) DYNJ70152MB, UDI-DI: 10889942722822(each), 40889942722823(case), Lot Number: 21ADA547; 85) DYNJ84239, UDI-DI: 10195327345624(each), 40195327345625(case), Lot Number: 23FBJ937; 86) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24IBL774; 87) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24JBC005; 88) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22CBY021; 89) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22EBG055; 90) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22LME863; 91) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23BMF790; 92) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23EMF082; 93) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMG079; 94) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMI718; 95) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMA136; 96) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMD502. 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-2094-2026&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-2094-2026&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-2094-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2094-2026 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-2094-2026&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-2094-2026&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-2094-2026/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-2094-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2094-2026",
            "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",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-07",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) 00-401993O, UDI-DI: 10195327517366(each), 40195327517367(case), Lot Number: 23KBH528; 2) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21BDB379; 3) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21CDB078; 4) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21IDC222; 5) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 21JDB458; 6) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22ADC105; 7) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22BDA862; 8) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22CDC433; 9) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22DDA763; 10) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 22FDB218; 11) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23BDB271; 12) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDA455; 13) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23DDB175; 14) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23FDC048; 15) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23GDB567; 16) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 23IDA297; 17) ACC010268B, UDI-DI: 10889942197477(each), 40889942197478(case), Lot Number: 24DDA188; 18) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24HDB961; 19) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24IDB060; 20) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24JDB298; 21) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 24KDA478; 22) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25DDB786; 23) ACC010268C, UDI-DI: 10198459018978(each), 40198459018979(case), Lot Number: 25EDA196; 24) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21CDC422; 25) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 21LDB744; 26) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 22BDB354; 27) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23EDB085; 28) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23FDB587; 29) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDA369; 30) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB672; 31) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23GDB680; 32) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 23HDA348; 33) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25ADB553; 34) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDA733; 35) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25BDB580; 36) ACC010487, UDI-DI: 10193489499926(each), 40193489499927(case), Lot Number: 25HDA748; 37) CVI3650, UDI-DI: 10653160256397(each), 40653160256398(case), Lot Number: 22EBO541; 38) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 22IBN124; 39) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23ABC583; 40) DYKM2170, UDI-DI: 10195327200091(each), 40195327200092(case), Lot Number: 23BBA792; 41) DYKM2274, UDI-DI: 10198459278884(each), 40198459278885(case), Lot Number: 25HBK806; 42) DYKMBNDL153C, UDI-DI: 10198459000430(each), 40198459000431(case), Lot Number: 24DBR907; 43) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBK412; 44) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 22IBM493; 45) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23ABK335; 46) DYKMBNDL43A, UDI-DI: 10195327241322(each), 40195327241323(case), Lot Number: 23BBS866; 47) DYKMBNDL43C, UDI-DI: 10198459000553(each), 40198459000554(case), Lot Number: 24DBS686; 48) DYNDA2076B, UDI-DI: 10195327572020(each), 40195327572021(case), Lot Number: 24ABI534; 49) DYNDA2076D, UDI-DI: 10198459216060(each), 40198459216061(case), Lot Number: 24LMH364; 50) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25FMF582; 51) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25HMH651; 52) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25IMA505; 53) DYNDA2076F, UDI-DI: 10198459290992(each), 40198459290993(case), Lot Number: 25KMH542; 54) DYNDA2322B, UDI-DI: 10195327299774(each), 40195327299775(case), Lot Number: 23FBW064; 55) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21ABI600; 56) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21DBA072; 57) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21JBV496; 58) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21LBT037; 59) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 21OBA058; 60) DYNDC2407A, UDI-DI: 10889942731503(each), 40889942731504(case), Lot Number: 22FME865; 61) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 23HMC992; 62) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24AMB024; 63) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24CMI922; 64) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24DMF048; 65) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 24IMD214; 66) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25EMA699; 67) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25FMG170; 68) DYNDC2407B, UDI-DI: 10195327274467(each), 40195327274468(case), Lot Number: 25IMA418; 69) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23FBG757; 70) DYNJ40500A, UDI-DI: 10195327350581(each), 40195327350582(case), Lot Number: 23HBB480; 71) DYNJ42694C, UDI-DI: 10195327514334(each), 40195327514335(case), Lot Number: 24ABW686; 72) DYNJ53427B, UDI-DI: 10193489248227(each), 40193489248228(case), Lot Number: 20LDC151; 73) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22IBQ424; 74) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 22LBG357; 75) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23BBB100; 76) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23CBT475; 77) DYNJ55546D, UDI-DI: 10195327056520(each), 40195327056521(case), Lot Number: 23GBK664; 78) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22BBP290; 79) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22IBO930; 80) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 22JBN171; 81) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 24EBG970; 82) DYNJ63199A, UDI-DI: 10193489311730(each), 40193489311731(case), Lot Number: 25CBK996; 83) DYNJ70141MB, UDI-DI: 10889942722808(each), 40889942722809(case), Lot Number: 21ADA546; 84) DYNJ70152MB, UDI-DI: 10889942722822(each), 40889942722823(case), Lot Number: 21ADA547; 85) DYNJ84239, UDI-DI: 10195327345624(each), 40195327345625(case), Lot Number: 23FBJ937; 86) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24IBL774; 87) DYNJ88152, UDI-DI: 10198459110313(each), 40198459110314(case), Lot Number: 24JBC005; 88) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22CBY021; 89) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22EBG055; 90) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 22LME863; 91) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23BMF790; 92) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23EMF082; 93) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMG079; 94) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23JMI718; 95) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMA136; 96) PICCNC0004, UDI-DI: 10195327059484(each), 40195327059485(case), Lot Number: 23LMD502",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}