{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1127-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Kits, trays, and packs labeled as follows:    a) ANTERIOR PACK, REF DYNJ64814A;   b) ARTHROGRAM TRAY, REF DYNDH1629;   c) CVL INSERTION KIT-LF, REF DYNJ48587A;   d) EXTREMITY CDS, REF CDS983313I;   e) EXTREMITY CDS, REF DYNJ902004D;   f) EXTREMITY CDS, REF DYNJ902004F;   g) EXTREMITY IV, REF CMPJ06040D;   h) EXTREMITY IV, REF CMPJ06040F;   i) EXTREMITY PROCEDURE, REF CDS981656I;   j) FACIAL PLASTY PACK, REF DYNJ55335D;   k) FOOT PROCEDURE, REF CDS981659I;   l) FOOT PROCEDURE, REF CDS981659J;   m) HAND, REF DYNJ902002J;   n) HAND PACK, REF DYNJ35744A;   o) HAND PACK, REF DYNJ68873C;   p) HAND PACK, REF DYNJ46211K;   q) KNEE ARTHROSCOPY CDS, REF CDS941004C;   r) KNEE PACK, REF DYNJ68512;   s) LACERATION TRAY, REF SUT21580;   t) LOWER EXTREMITY, REF DYNJ907121F;   u) LOWER EXTREMITY, REF DYNJ46222M;   v) LOWER EXTREMITY PACK, REF DYNJ67216C;   w) LOWER EXTREMITY PACK, REF DYNJ67216D;   x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892;   y) PODIATRY PACK, REF DYNJ68347A;   z) PODIATRY PACK, REF DYNJ68347B;   aa) PODIATRY PACK-LF, REF DYNJ34648D;   bb) POSTERIOR PACK, REF DYNJ64576A;   cc) SHOULDER, REF DYNJ903011J;   dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G;   ee) SHOULDER KIT, REF DYNJ907705D;   ff) SMALL HAND CDS, REF DYNJ902002G;   gg) SMALL HAND CDS, REF DYNJ902002I;   hh) SMALL HAND PACK, REF CMPJ06038F;   ii) SMALL HAND PACK, REF CMPJ06038G;   jj) TOTAL KNEE, REF DYNJ909159;   kk) TOTAL KNEE CDS, REF CDS982823P;   ll) TOTAL KNEE CDS, REF CDS982823Q;   mm) TRIGGER FINGER KIT, REF DYNJ68406;   nn) UPPER EXTREMITY, REF DYNJ907130C",
  "description": "FDA recall Z-1127-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) ANTERIOR PACK, REF DYNJ64814A;   b) ARTHROGRAM TRAY, REF DYNDH1629;   c) CVL INSERTION KIT-LF, REF DYNJ48587A;   d) EXTREMITY CDS, REF CDS983313I;   e) EXTREMITY CDS, REF DYNJ902004D;   f) EXTREMITY CDS, REF DYNJ902004F;   g) EXTREMITY IV, REF CMPJ06040D;   h) EXTREMITY IV, REF CMPJ06040F;   i) EXTREMITY PROCEDURE, REF CDS981656I;   j) FACIAL PLASTY PACK, REF DYNJ55335D;   k) FOOT PROCEDURE, REF CDS981659I;   l) FOOT PROCEDURE, REF CDS981659J;   m) HAND, REF DYNJ902002J;   n) HAND PACK, REF DYNJ35744A;   o) HAND PACK, REF DYNJ68873C;   p) HAND PACK, REF DYNJ46211K;   q) KNEE ARTHROSCOPY CDS, REF CDS941004C;   r) KNEE PACK, REF DYNJ68512;   s) LACERATION TRAY, REF SUT21580;   t) LOWER EXTREMITY, REF DYNJ907121F;   u) LOWER EXTREMITY, REF DYNJ46222M;   v) LOWER EXTREMITY PACK, REF DYNJ67216C;   w) LOWER EXTREMITY PACK, REF DYNJ67216D;   x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892;   y) PODIATRY PACK, REF DYNJ68347A;   z) PODIATRY PACK, REF DYNJ68347B;   aa) PODIATRY PACK-LF, REF DYNJ34648D;   bb) POSTERIOR PACK, REF DYNJ64576A;   cc) SHOULDER, REF DYNJ903011J;   dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G;   ee) SHOULDER KIT, REF DYNJ907705D;   ff) SMALL HAND CDS, REF DYNJ902002G;   gg) SMALL HAND CDS, REF DYNJ902002I;   hh) SMALL HAND PACK, REF CMPJ06038F;   ii) SMALL HAND PACK, REF CMPJ06038G;   jj) TOTAL KNEE, REF DYNJ909159;   kk) TOTAL KNEE CDS, REF CDS982823P;   ll) TOTAL KNEE CDS, REF CDS982823Q;   mm) TRIGGER FINGER KIT, REF DYNJ68406;   nn) UPPER EXTREMITY, REF DYNJ907130C (Devices, Class I). 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,
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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-1127-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Kits, trays, and packs labeled as follows:    a) ANTERIOR PACK, REF DYNJ64814A;   b) ARTHROGRAM TRAY, REF DYNDH1629;   c) CVL INSERTION KIT-LF, REF DYNJ48587A;   d) EXTREMITY CDS, REF CDS983313I;   e) EXTREMITY CDS, REF DYNJ902004D;   f) EXTREMITY CDS, REF DYNJ902004F;   g) EXTREMITY IV, REF CMPJ06040D;   h) EXTREMITY IV, REF CMPJ06040F;   i) EXTREMITY PROCEDURE, REF CDS981656I;   j) FACIAL PLASTY PACK, REF DYNJ55335D;   k) FOOT PROCEDURE, REF CDS981659I;   l) FOOT PROCEDURE, REF CDS981659J;   m) HAND, REF DYNJ902002J;   n) HAND PACK, REF DYNJ35744A;   o) HAND PACK, REF DYNJ68873C;   p) HAND PACK, REF DYNJ46211K;   q) KNEE ARTHROSCOPY CDS, REF CDS941004C;   r) KNEE PACK, REF DYNJ68512;   s) LACERATION TRAY, REF SUT21580;   t) LOWER EXTREMITY, REF DYNJ907121F;   u) LOWER EXTREMITY, REF DYNJ46222M;   v) LOWER EXTREMITY PACK, REF DYNJ67216C;   w) LOWER EXTREMITY PACK, REF DYNJ67216D;   x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892;   y) PODIATRY PACK, REF DYNJ68347A;   z) PODIATRY PACK, REF DYNJ68347B;   aa) PODIATRY PACK-LF, REF DYNJ34648D;   bb) POSTERIOR PACK, REF DYNJ64576A;   cc) SHOULDER, REF DYNJ903011J;   dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G;   ee) SHOULDER KIT, REF DYNJ907705D;   ff) SMALL HAND CDS, REF DYNJ902002G;   gg) SMALL HAND CDS, REF DYNJ902002I;   hh) SMALL HAND PACK, REF CMPJ06038F;   ii) SMALL HAND PACK, REF CMPJ06038G;   jj) TOTAL KNEE, REF DYNJ909159;   kk) TOTAL KNEE CDS, REF CDS982823P;   ll) TOTAL KNEE CDS, REF CDS982823Q;   mm) TRIGGER FINGER KIT, REF DYNJ68406;   nn) UPPER EXTREMITY, REF DYNJ907130C",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1127-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1127-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Kits, trays, and packs labeled as follows:    a) ANTERIOR PACK, REF DYNJ64814A;   b) ARTHROGRAM TRAY, REF DYNDH1629;   c) CVL INSERTION KIT-LF, REF DYNJ48587A;   d) EXTREMITY CDS, REF CDS983313I;   e) EXTREMITY CDS, REF DYNJ902004D;   f) EXTREMITY CDS, REF DYNJ902004F;   g) EXTREMITY IV, REF CMPJ06040D;   h) EXTREMITY IV, REF CMPJ06040F;   i) EXTREMITY PROCEDURE, REF CDS981656I;   j) FACIAL PLASTY PACK, REF DYNJ55335D;   k) FOOT PROCEDURE, REF CDS981659I;   l) FOOT PROCEDURE, REF CDS981659J;   m) HAND, REF DYNJ902002J;   n) HAND PACK, REF DYNJ35744A;   o) HAND PACK, REF DYNJ68873C;   p) HAND PACK, REF DYNJ46211K;   q) KNEE ARTHROSCOPY CDS, REF CDS941004C;   r) KNEE PACK, REF DYNJ68512;   s) LACERATION TRAY, REF SUT21580;   t) LOWER EXTREMITY, REF DYNJ907121F;   u) LOWER EXTREMITY, REF DYNJ46222M;   v) LOWER EXTREMITY PACK, REF DYNJ67216C;   w) LOWER EXTREMITY PACK, REF DYNJ67216D;   x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892;   y) PODIATRY PACK, REF DYNJ68347A;   z) PODIATRY PACK, REF DYNJ68347B;   aa) PODIATRY PACK-LF, REF DYNJ34648D;   bb) POSTERIOR PACK, REF DYNJ64576A;   cc) SHOULDER, REF DYNJ903011J;   dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G;   ee) SHOULDER KIT, REF DYNJ907705D;   ff) SMALL HAND CDS, REF DYNJ902002G;   gg) SMALL HAND CDS, REF DYNJ902002I;   hh) SMALL HAND PACK, REF CMPJ06038F;   ii) SMALL HAND PACK, REF CMPJ06038G;   jj) TOTAL KNEE, REF DYNJ909159;   kk) TOTAL KNEE CDS, REF CDS982823P;   ll) TOTAL KNEE CDS, REF CDS982823Q;   mm) TRIGGER FINGER KIT, REF DYNJ68406;   nn) UPPER EXTREMITY, REF DYNJ907130C",
      "text": "The FDA logged enforcement record Z-1127-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Kits, trays, and packs labeled as follows:    a) ANTERIOR PACK, REF DYNJ64814A;   b) ARTHROGRAM TRAY, REF DYNDH1629;   c) CVL INSERTION KIT-LF, REF DYNJ48587A;   d) EXTREMITY CDS, REF CDS983313I;   e) EXTREMITY CDS, REF DYNJ902004D;   f) EXTREMITY CDS, REF DYNJ902004F;   g) EXTREMITY IV, REF CMPJ06040D;   h) EXTREMITY IV, REF CMPJ06040F;   i) EXTREMITY PROCEDURE, REF CDS981656I;   j) FACIAL PLASTY PACK, REF DYNJ55335D;   k) FOOT PROCEDURE, REF CDS981659I;   l) FOOT PROCEDURE, REF CDS981659J;   m) HAND, REF DYNJ902002J;   n) HAND PACK, REF DYNJ35744A;   o) HAND PACK, REF DYNJ68873C;   p) HAND PACK, REF DYNJ46211K;   q) KNEE ARTHROSCOPY CDS, REF CDS941004C;   r) KNEE PACK, REF DYNJ68512;   s) LACERATION TRAY, REF SUT21580;   t) LOWER EXTREMITY, REF DYNJ907121F;   u) LOWER EXTREMITY, REF DYNJ46222M;   v) LOWER EXTREMITY PACK, REF DYNJ67216C;   w) LOWER EXTREMITY PACK, REF DYNJ67216D;   x) PACK,POSTERIOR SPINAL FUSION, REF DYNJ906892;   y) PODIATRY PACK, REF DYNJ68347A;   z) PODIATRY PACK, REF DYNJ68347B;   aa) PODIATRY PACK-LF, REF DYNJ34648D;   bb) POSTERIOR PACK, REF DYNJ64576A;   cc) SHOULDER, REF DYNJ903011J;   dd) SHOULDER ARTHROTOMY PROCEDURE, REF CDS981658G;   ee) SHOULDER KIT, REF DYNJ907705D;   ff) SMALL HAND CDS, REF DYNJ902002G;   gg) SMALL HAND CDS, REF DYNJ902002I;   hh) SMALL HAND PACK, REF CMPJ06038F;   ii) SMALL HAND PACK, REF CMPJ06038G;   jj) TOTAL KNEE, REF DYNJ909159;   kk) TOTAL KNEE CDS, REF CDS982823P;   ll) TOTAL KNEE CDS, REF CDS982823Q;   mm) TRIGGER FINGER KIT, REF DYNJ68406;   nn) UPPER EXTREMITY, REF DYNJ907130C — reason: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-15. Affected lots/codes: a) REF DYNJ64814A, UDI/DI 40195327112807 (case), 10195327112806 (unit), Lot Numbers:  22FBD779, 22JBN895;   b) REF DYNDH1629, UDI/DI 40193489917360 (case), 10193489917369 (unit), Lot Numbers:  22ABP606;   c) REF DYNJ48587A, UDI/DI 40889942313106 (case), 10889942313105 (unit), Lot Numbers:  22JBQ342, 23ABL345, 23CBJ954, 23DBK384, 23FBQ607;   d) REF CDS983313I, UDI/DI 40193489424540 (case), 10193489424539 (unit), Lot Numbers:  22DDA444, 22EDB075, 23ADB093, 23CDC442, 23DDA819, 23EDC367;   e) REF DYNJ902004D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers:  22FBR327, 22JBQ099;   f) REF DYNJ902004F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers:  23BBF818, 23BBN981, 23HBL676, 23IBA162, 23IBJ945;   g) REF CMPJ06040D, UDI/DI 40193489351782 (case), 10193489351781 (unit), Lot Numbers:  22EBU873, 22IBA206;   h) REF CMPJ06040F, UDI/DI 40195327257591 (case), 10195327257590 (unit), Lot Numbers:  23ABN951, 23ABU853, 23GBV583, 23GBW733, 23HBK120;   i) REF CDS981656I, UDI/DI 40193489433884 (case), 10193489433883 (unit), Lot Numbers:   22BDB050, 22EDB527, 22FDB578, 23BDA698, 23BDB738, 23EDA039;     j) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers:  23JBB690;   k) REF CDS981659I, UDI/DI 40193489433907 (case), 10193489433906 (unit), Lot Numbers:  23BDB207, 23DDA594, 23EDA040, 23FDB570;   l) REF CDS981659J, UDI/DI 40195327398508 (case), 10195327398507 (unit), Lot Numbers:  23JBM035;   m) REF DYNJ902002J, UDI/DI 40195327516070 (case), 10195327516079 (unit), Lot Numbers:  22DBB588, 23DBA171, 23EBL341, 23FBA124, 23FBU113, 23FBV329, 23GBN600, 23GBQ956, 23JBA529;   n) REF DYNJ35744A, UDI/DI 40889942600596 (case), 10889942600595 (unit), Lot Numbers:  22DBB588;   o) REF DYNJ68873C, UDI/DI 40195327375691 (case), 10195327375690 (unit), Lot Numbers:  23FBA124, 23FBU113, 23FBV329, 23GBQ956;   p) REF DYNJ46211K, UDI/DI 40195327407484 (case), 10195327407483 (unit), Lot Numbers:  23DBA171, 23EBL341, 23GBN600, 23JBA529;   q) REF CDS941004C, UDI/DI 40888277507471 (case), 10888277507470 (unit), Lot Numbers:  22ALA255, 22IMA552;   r) REF DYNJ68512, UDI/DI 40193489828956 (case), 10193489828955 (unit), Lot Numbers:   21KBI896, 22BBV355, 22EBN387, 22EBP166, 22FBA911, 22FBL484, 22IBO503, 22JBW455, 22KBM697, 22LBN605, 22LBQ786, 23BBB214, 23BBS153, 23EBO560, 23GBN713, 23HBH102, 23JBL709;   s) REF SUT21580, UDI/DI 40653160991077 (case), 10653160991076 (unit), Lot Numbers:   23EBL458;   t) REF DYNJ907121F, UDI/DI 40195327222087 (case), 10195327222086 (unit), Lot Numbers:  22LBR588;   u) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers:  23HBP767, 23IBW177;   v) REF DYNJ67216C, UDI/DI 40195327280674 (case), 10195327280673 (unit), Lot Numbers:  22LLA847, 23CLA146;   w) REF DYNJ67216D, UDI/DI 40195327405183 (case), 10195327405182 (unit), Lot Numbers:  23ELA164, 23FLA372;   x) REF DYNJ906892, UDI/DI 40193489281461 (case), 10193489281460 (unit), Lot Numbers:  22GBI467, 22GBM602, 22OBH187, 22OBJ425, 22OBK650;   y) REF DYNJ68347A, UDI/DI 40193489934107 (case), 10193489934106 (unit), Lot Numbers:  22ABK059, 22BBU107, 22CBS838;   z) REF DYNJ68347B, UDI/DI 40195327141197 (case), 10195327141196 (unit), Lot Numbers:  22FBG492, 22FBU866;   aa) REF DYNJ34648D, UDI/DI 40193489916165 (case), 10193489916164 (unit), Lot Numbers:  22HBH536;   bb) REF DYNJ64576A, UDI/DI 40195327111954 (case), 10195327111953 (unit), Lot Numbers:  22GBL600;   cc) REF DYNJ903011J, UDI/DI 40195327437573 (case), 10195327437572 (unit), Lot Numbers:  23IBF175, 23JBS067;   dd) REF CDS981658G, UDI/DI 40193489876827 (case), 10193489876826 (unit), Lot Numbers:  22CDC277, 23DDB287;   ee) REF DYNJ907705D, UDI/DI 40195327375783 (case), 10195327375782 (unit), Lot Numbers:  23EBU785, 23JBF717, 23KBA709;   ff) REF DYNJ902002G, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers:  22HBA403, 22HBS428, 22IBE726;   gg) REF DYNJ902002I, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers:  22LBS865, 23ABO144, 23BBR667, 23DBS266, 23EBT050, 23FBE713, 23HBQ460;   hh) REF CMPJ06038F, UDI/DI 40193489351737 (case), 10193489351736 (unit), Lot Numbers:  22EBI104, 22HBO484;   ii) REF CMPJ06038G, UDI/DI 40195327257621 (case), 10195327257620 (unit), Lot Numbers:  22KBG879, 22KBU962, 23BBD874, 23DBA902, 23DBK147, 23EBQ126, 23GBQ295;   jj) REF DYNJ909159, UDI/DI 40195327280896 (case), 10195327280895 (unit), Lot Numbers:  23EBS908;   kk) REF CDS982823P, UDI/DI 40193489402760 (case), 10193489402759 (unit), Lot Numbers:  22OBI091;   ll) REF CDS982823Q, UDI/DI 40195327238340 (case), 10195327238339 (unit), Lot Numbers:  23ABT038, 23BBK666, 23EBJ570, 23FBL610, 23HBE191, 23JBD296, 23JBR325;   mm) REF DYNJ68406, UDI/DI 40193489440363 (case), 10193489440362 (unit), Lot Numbers:  22OBK988;   nn) REF DYNJ907130C, UDI/DI 40193489821636 (case), 10193489821635 (unit), Lot Numbers:  23ABD199. 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-1127-2024&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-1127-2024&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-1127-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1127-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-1127-2024&lang=eng",
        "value": "Class I",
        "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-1127-2024&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-1127-2024/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
      },
      "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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          "item": {
            "Field": "Recall number",
            "Value": "Z-1127-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class I",
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
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            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components):  0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.",
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          "item": {
            "Field": "Initiated",
            "Value": "2023-11-15",
            "Status": "recorded"
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