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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3121-2024.jsonld",
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  "name": "Medline convenience kits containing semi-rigid suction liners labeled as follows:  a) LAMINECTOMY CDS, Pack Number CDS981510L;   b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;   c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;   d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;   e) LAMINECTOMY, Pack Number DYNJ908091B;   f) PODIATRY, Pack Number DYNJ908092C;   g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;   h) CRANI, Pack Number DYNJ908097A;   i) HIP PINNING, Pack Number DYNJ908102B;   j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;   k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;   m) HAND-LF, Pack Number DYNJ908425;   n) TOTAL JOINT, Pack Number DYNJ908660A;   o) MERCY TIFFIN HAND, Pack Number DYNJ909734;   p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;   q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;   r) ACL-WHSC, Pack Number DYNJ910074A;   s) EXTREMITY-WHSC, Pack Number DYNJ910077;   t) EXTREMITY-WHSC, Pack Number DYNJ910077A;   u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;   v) MICRODISC, Pack Number DYNJ910370;   w) MTHZ TOTAL HIP, Pack Number DYNJC9311L",
  "description": "FDA recall Z-3121-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits containing semi-rigid suction liners labeled as follows:  a) LAMINECTOMY CDS, Pack Number CDS981510L;   b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;   c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;   d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;   e) LAMINECTOMY, Pack Number DYNJ908091B;   f) PODIATRY, Pack Number DYNJ908092C;   g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;   h) CRANI, Pack Number DYNJ908097A;   i) HIP PINNING, Pack Number DYNJ908102B;   j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;   k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;   m) HAND-LF, Pack Number DYNJ908425;   n) TOTAL JOINT, Pack Number DYNJ908660A;   o) MERCY TIFFIN HAND, Pack Number DYNJ909734;   p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;   q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;   r) ACL-WHSC, Pack Number DYNJ910074A;   s) EXTREMITY-WHSC, Pack Number DYNJ910077;   t) EXTREMITY-WHSC, Pack Number DYNJ910077A;   u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;   v) MICRODISC, Pack Number DYNJ910370;   w) MTHZ TOTAL HIP, Pack Number DYNJC9311L (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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline convenience kits containing semi-rigid suction liners labeled as follows:  a) LAMINECTOMY CDS, Pack Number CDS981510L;   b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;   c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;   d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;   e) LAMINECTOMY, Pack Number DYNJ908091B;   f) PODIATRY, Pack Number DYNJ908092C;   g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;   h) CRANI, Pack Number DYNJ908097A;   i) HIP PINNING, Pack Number DYNJ908102B;   j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;   k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;   m) HAND-LF, Pack Number DYNJ908425;   n) TOTAL JOINT, Pack Number DYNJ908660A;   o) MERCY TIFFIN HAND, Pack Number DYNJ909734;   p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;   q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;   r) ACL-WHSC, Pack Number DYNJ910074A;   s) EXTREMITY-WHSC, Pack Number DYNJ910077;   t) EXTREMITY-WHSC, Pack Number DYNJ910077A;   u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;   v) MICRODISC, Pack Number DYNJ910370;   w) MTHZ TOTAL HIP, Pack Number DYNJC9311L",
    "manufacturer": {
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      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3121-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3121-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline convenience kits containing semi-rigid suction liners labeled as follows:  a) LAMINECTOMY CDS, Pack Number CDS981510L;   b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;   c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;   d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;   e) LAMINECTOMY, Pack Number DYNJ908091B;   f) PODIATRY, Pack Number DYNJ908092C;   g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;   h) CRANI, Pack Number DYNJ908097A;   i) HIP PINNING, Pack Number DYNJ908102B;   j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;   k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;   m) HAND-LF, Pack Number DYNJ908425;   n) TOTAL JOINT, Pack Number DYNJ908660A;   o) MERCY TIFFIN HAND, Pack Number DYNJ909734;   p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;   q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;   r) ACL-WHSC, Pack Number DYNJ910074A;   s) EXTREMITY-WHSC, Pack Number DYNJ910077;   t) EXTREMITY-WHSC, Pack Number DYNJ910077A;   u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;   v) MICRODISC, Pack Number DYNJ910370;   w) MTHZ TOTAL HIP, Pack Number DYNJC9311L",
      "text": "The FDA logged enforcement record Z-3121-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline convenience kits containing semi-rigid suction liners labeled as follows:  a) LAMINECTOMY CDS, Pack Number CDS981510L;   b) ORTHO TRAUMA-LF, Pack Number DYNJ900720D;   c) ORTHO TRAUMA-LF, Pack Number DYNJ900720F;   d) KNEE ARTHROSCOPY, Pack Number DYNJ908090C;   e) LAMINECTOMY, Pack Number DYNJ908091B;   f) PODIATRY, Pack Number DYNJ908092C;   g) ANTERIOR TOTAL HIP, Pack Number DYNJ908095B;   h) CRANI, Pack Number DYNJ908097A;   i) HIP PINNING, Pack Number DYNJ908102B;   j) (76) LOWER EXTREMITY, Pack Number DYNJ908103B;   k) SHOULDER ARTHROSCOPY, Pack Number DYNJ908110B;   m) HAND-LF, Pack Number DYNJ908425;   n) TOTAL JOINT, Pack Number DYNJ908660A;   o) MERCY TIFFIN HAND, Pack Number DYNJ909734;   p) MERCY TIFFIN TOTAL KNEE, Pack Number DYNJ909738;   q) MTHZ KNEE ARTHROSCOPY, Pack Number DYNJ909740;   r) ACL-WHSC, Pack Number DYNJ910074A;   s) EXTREMITY-WHSC, Pack Number DYNJ910077;   t) EXTREMITY-WHSC, Pack Number DYNJ910077A;   u) KNEE ARTHROSCOPY-WHSC, Pack Number DYNJ910080A;   v) MICRODISC, Pack Number DYNJ910370;   w) MTHZ TOTAL HIP, Pack Number DYNJC9311L — reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-27. Affected lots/codes: a) CDS981510L:  UDI/DI case 40195327195435, UDI/DI each 10195327195434, Lot Numbers:  23LDB386, 23LDB793;  b) DYNJ900720D:  UDI/DI case 40193489951593, UDI/DI each 10193489951592, Lot Numbers:23LBT897;    c) DYNJ900720F:  UDI/DI case 40195327635337, UDI/DI each 10195327635336, Lot Numbers: 24CBC838, 24EBH235;    d) DYNJ908090C:  UDI/DI case 40195327507245, UDI/DI each 10195327507244, Lot Numbers: 24CBH612, 24FBA023;    e) DYNJ908091B:  UDI/DI case 40195327507023, UDI/DI each 10195327507022, Lot Numbers: 24CBK626;   f) DYNJ908092C:  UDI/DI case 40195327507030, UDI/DI each 10195327507039, Lot Numbers:  23LBU932, 24ABT063, 24CBP714;  g) DYNJ908095B:  UDI/ DI case 40195327507184, UDI/DI each 10195327507183, Lot Numbers: 24ABO437, 24ABW989, 24EBH236;  h) DYNJ908097A:  UDI/DI case 40195327507078, UDI/DI each 10195327507077, Lot Numbers:23LBV779, 24CBU878;  i) DYNJ908102B:  UDI/DI case 40195327507191, UDI/DI each 10195327507190, Lot Numbers: 24BBI407;    j) DYNJ908103B:  UDI/DI case 40195327507108, UDI/DI each 10195327507107, Lot Numbers:  24CBO655;  k) DYNJ908110B:  UDI/DI case 40195327507160, UDI/DI each 10195327507169, Lot Numbers: 24ABS361, 24CBE409;   m) DYNJ908425:  UDI/DI case 40195327072613, UDI/DI each 10195327072612, Lot Numbers:  24ABL204;  n) DYNJ908660A:  UDI/DI case 40195327219674, UDI/DI each 10195327219673, Lot Numbers: 23LMC113, 24AME301, 24AMJ018, 24CMH075;   o) DYNJ909734:  UDI/DI case 40195327464708, UDI/DI each 10195327464707, Lot Numbers:  24ABA222, 24CBO720;  p) DYNJ909738:  UDI/DI case 40195327464739, UDI/DI each 10195327464738, Lot Numbers: 24ABY029, 4EBH232;   q) DYNJ909740:  UDI/DI case 40195327464753, UDI/DI each 10195327464752, Lot Numbers:  24BBK598;  r) DYNJ910074A:  UDI/DI case 40195327639281, UDI/DI each 10195327639280, Lot Numbers:  24CBA353;    s) DYNJ910077:  UDI/DI case 40195327568383, UDI/DI each 10195327568382, Lot Numbers:  23LBS081;  t) DYNJ910077A:  UDI/DI case 40195327639342, UDI/DI each 10195327639341, Lot Numbers:  24CBM378, 24DBC165;  u) DYNJ910080A:  UDI/DI case 40195327639304, UDI/DI each 10195327639303, Lot Numbers:  24BBS375;  v) DYNJ910370:  UDI/DI case 40195327654536, UDI/DI each 10195327654535, Lot Numbers:  24DDB322, 24EDA091;  w) DYNJC9311L:  UDI/DI case 40195327464777, UDI/DI each 10195327464776, Lot Numbers:  24CDC175. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-3121-2024&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-3121-2024&lang=eng"
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      "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-3121-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3121-2024 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
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      "grounding": {
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        "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-3121-2024&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-3121-2024&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-3121-2024/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
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      "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."
    }
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      "name": "FDA recall details — Z-3121-2024",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-3121-2024",
            "Status": "recorded"
          }
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        {
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "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": "Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-06-27",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) CDS981510L:  UDI/DI case 40195327195435, UDI/DI each 10195327195434, Lot Numbers:  23LDB386, 23LDB793;  b) DYNJ900720D:  UDI/DI case 40193489951593, UDI/DI each 10193489951592, Lot Numbers:23LBT897;    c) DYNJ900720F:  UDI/DI case 40195327635337, UDI/DI each 10195327635336, Lot Numbers: 24CBC838, 24EBH235;    d) DYNJ908090C:  UDI/DI case 40195327507245, UDI/DI each 10195327507244, Lot Numbers: 24CBH612, 24FBA023;    e) DYNJ908091B:  UDI/DI case 40195327507023, UDI/DI each 10195327507022, Lot Numbers: 24CBK626;   f) DYNJ908092C:  UDI/DI case 40195327507030, UDI/DI each 10195327507039, Lot Numbers:  23LBU932, 24ABT063, 24CBP714;  g) DYNJ908095B:  UDI/ DI case 40195327507184, UDI/DI each 10195327507183, Lot Numbers: 24ABO437, 24ABW989, 24EBH236;  h) DYNJ908097A:  UDI/DI case 40195327507078, UDI/DI each 10195327507077, Lot Numbers:23LBV779, 24CBU878;  i) DYNJ908102B:  UDI/DI case 40195327507191, UDI/DI each 10195327507190, Lot Numbers: 24BBI407;    j) DYNJ908103B:  UDI/DI case 40195327507108, UDI/DI each 10195327507107, Lot Numbers:  24CBO655;  k) DYNJ908110B:  UDI/DI case 40195327507160, UDI/DI each 10195327507169, Lot Numbers: 24ABS361, 24CBE409;   m) DYNJ908425:  UDI/DI case 40195327072613, UDI/DI each 10195327072612, Lot Numbers:  24ABL204;  n) DYNJ908660A:  UDI/DI case 40195327219674, UDI/DI each 10195327219673, Lot Numbers: 23LMC113, 24AME301, 24AMJ018, 24CMH075;   o) DYNJ909734:  UDI/DI case 40195327464708, UDI/DI each 10195327464707, Lot Numbers:  24ABA222, 24CBO720;  p) DYNJ909738:  UDI/DI case 40195327464739, UDI/DI each 10195327464738, Lot Numbers: 24ABY029, 4EBH232;   q) DYNJ909740:  UDI/DI case 40195327464753, UDI/DI each 10195327464752, Lot Numbers:  24BBK598;  r) DYNJ910074A:  UDI/DI case 40195327639281, UDI/DI each 10195327639280, Lot Numbers:  24CBA353;    s) DYNJ910077:  UDI/DI case 40195327568383, UDI/DI each 10195327568382, Lot Numbers:  23LBS081;  t) DYNJ910077A:  UDI/DI case 40195327639342, UDI/DI each 10195327639341, Lot Numbers:  24CBM378, 24DBC165;  u) DYNJ910080A:  UDI/DI case 40195327639304, UDI/DI each 10195327639303, Lot Numbers:  24BBS375;  v) DYNJ910370:  UDI/DI case 40195327654536, UDI/DI each 10195327654535, Lot Numbers:  24DDB322, 24EDA091;  w) DYNJC9311L:  UDI/DI case 40195327464777, UDI/DI each 10195327464776, Lot Numbers:  24CDC175",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}