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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1891-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ARTERIOGRAM TRAY\t00-402001T, 00-402001U  \t  CATH LAB-VEIN PROCEDURES\tDYNJ60329A  \t  CENTRAL VENOUS ACCESS PACK-LF\tCVI5070  \t  FISTULAGRAM PACK\tDYNJ66259  \t  INVASIVE LINE INSERTION\tDYNJ44123C  \t  NON VASCULAR PACK\tDYNJ68037B, DYNJ68037C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005G  \t  PICC LINEPACK (PCLUI)642-LF\tDYNJ47717B  \t  PICC PHC\tDYNJ37484C",
  "description": "FDA recall Z-1891-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ARTERIOGRAM TRAY\t00-402001T, 00-402001U  \t  CATH LAB-VEIN PROCEDURES\tDYNJ60329A  \t  CENTRAL VENOUS ACCESS PACK-LF\tCVI5070  \t  FISTULAGRAM PACK\tDYNJ66259  \t  INVASIVE LINE INSERTION\tDYNJ44123C  \t  NON VASCULAR PACK\tDYNJ68037B, DYNJ68037C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005G  \t  PICC LINEPACK (PCLUI)642-LF\tDYNJ47717B  \t  PICC PHC\tDYNJ37484C (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/",
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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": {
      "@type": "schema:GovernmentOrganization",
      "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-1891-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ARTERIOGRAM TRAY\t00-402001T, 00-402001U  \t  CATH LAB-VEIN PROCEDURES\tDYNJ60329A  \t  CENTRAL VENOUS ACCESS PACK-LF\tCVI5070  \t  FISTULAGRAM PACK\tDYNJ66259  \t  INVASIVE LINE INSERTION\tDYNJ44123C  \t  NON VASCULAR PACK\tDYNJ68037B, DYNJ68037C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005G  \t  PICC LINEPACK (PCLUI)642-LF\tDYNJ47717B  \t  PICC PHC\tDYNJ37484C",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1891-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1891-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ARTERIOGRAM TRAY\t00-402001T, 00-402001U  \t  CATH LAB-VEIN PROCEDURES\tDYNJ60329A  \t  CENTRAL VENOUS ACCESS PACK-LF\tCVI5070  \t  FISTULAGRAM PACK\tDYNJ66259  \t  INVASIVE LINE INSERTION\tDYNJ44123C  \t  NON VASCULAR PACK\tDYNJ68037B, DYNJ68037C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005G  \t  PICC LINEPACK (PCLUI)642-LF\tDYNJ47717B  \t  PICC PHC\tDYNJ37484C",
      "text": "The FDA logged enforcement record Z-1891-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ARTERIOGRAM TRAY\t00-402001T, 00-402001U  \t  CATH LAB-VEIN PROCEDURES\tDYNJ60329A  \t  CENTRAL VENOUS ACCESS PACK-LF\tCVI5070  \t  FISTULAGRAM PACK\tDYNJ66259  \t  INVASIVE LINE INSERTION\tDYNJ44123C  \t  NON VASCULAR PACK\tDYNJ68037B, DYNJ68037C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005G  \t  PICC LINEPACK (PCLUI)642-LF\tDYNJ47717B  \t  PICC PHC\tDYNJ37484C — reason: Unapproved design changes to the products outside of the 510(k) clearance.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-27. Affected lots/codes: 00-402001T  UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS  23EBT729    23GBR995    23GBS336     00-402001U  UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS  23JBU819    23LBG449    24ABS585    24CBF190    24DBA960    24EBB048    24FBN231    24HBA892    24IBD316    24IBS824     DYNJ60329A  UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT  24ABP714     CVI5070  UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT  24FBF359     DYNJ66259  UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT  22FMB867     DYNJ44123C  UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS  24ABQ097    24DMH637    24FMG692    24GMA523    24HME792    24JMA878    24JMI393     DYNJ68037B  UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT  24HBK116     DYNJ68037C  UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT  25BBO522    25DBR880     DYNJ0774005G  UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS  23DMC237    23EMC431    23FMG987    23HBL979    23JBG840    23KBJ401    23LBR858    24CBB784    24EBA777     DYNJ47717B  UDI-DI 10195327355302 (EA) 40195327355303 (CS) LOTS  23GMB288    23HMA341    23HMH322     DYNJ37484C  UDI-DI 10195327397340 (EA) 40195327397341 (CS) LOTS  24EDB695    24HDC050    24IMH716    24JMH721    24KMG262  ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.***  00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140;  DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447;  DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943;  DYNJ44123C Lots 25BMC026;  DYNJ47717B Lots 23DME176;  DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997. 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-1891-2026&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-1891-2026&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-1891-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1891-2026 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-1891-2026&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-1891-2026&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-1891-2026/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": [
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      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1891-2026",
      "numberOfItems": 9,
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          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1891-2026",
            "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": "Unapproved design changes to the products outside of the 510(k) clearance.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-27",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "00-402001T  UDI-DI 10193489939682 (EA) 40193489939683 (CS) LOTS  23EBT729    23GBR995    23GBS336     00-402001U  UDI-DI 10195327517380 (EA) 40195327517381 (CS) LOTS  23JBU819    23LBG449    24ABS585    24CBF190    24DBA960    24EBB048    24FBN231    24HBA892    24IBD316    24IBS824     DYNJ60329A  UDI-DI 10193489972221 (EA) 40193489972222 (CS) LOT  24ABP714     CVI5070  UDI-DI 10195327526061 (EA) 40195327526062 (CS) LOT  24FBF359     DYNJ66259  UDI-DI 10193489325485 (EA) 40193489325486 (CS) LOT  22FMB867     DYNJ44123C  UDI-DI 10195327599140 (EA) 40195327599141 (CS) LOTS  24ABQ097    24DMH637    24FMG692    24GMA523    24HME792    24JMA878    24JMI393     DYNJ68037B  UDI-DI 10195327476458 (EA) 40195327476459 (CS) LOT  24HBK116     DYNJ68037C  UDI-DI 10198459239328 (EA) 40198459239329 (CS) LOT  25BBO522    25DBR880     DYNJ0774005G  UDI-DI 10193489271485 (EA) 40193489271486 (CS) LOTS  23DMC237    23EMC431    23FMG987    23HBL979    23JBG840    23KBJ401    23LBR858    24CBB784    24EBA777     DYNJ47717B  UDI-DI 10195327355302 (EA) 40195327355303 (CS) LOTS  23GMB288    23HMA341    23HMH322     DYNJ37484C  UDI-DI 10195327397340 (EA) 40195327397341 (CS) LOTS  24EDB695    24HDC050    24IMH716    24JMH721    24KMG262  ***Updated 5/20/26 - The following lots were included in the customer notification but not the FDA submission.***  00-402001T Lots 21GBL509 21JBN647 21JBZ697 22BBX248 22DBL467 22DBS962 22GBC939 22HBO291 22HBO322 22IBN444 22IBO023 22KBT315 23BBA151 23CBI235 23DBM140;  DYNJ0774005G Lots 21AMC932 21CMB295 21EMA842 21EMA842Z 21GME190 21IMF074 21JMA971 22AMB224 22CMF849 22CMG025 22DMF774 22HMD145 22HMH991 22JMF788 23AMH034 23CMA447;  DYNJ37484C Lots 23EDA007 23GDA068 23HDC049 23JDA140 23LDA212 24BDA222 24DDA235 25AMA456 25AMH943;  DYNJ44123C Lots 25BMC026;  DYNJ47717B Lots 23DME176;  DYNJ68037B Lots 23JBM013 23LBR847 24CBM608 24DBQ050 24HBT816 25ABA997",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}