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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2037-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A.",
  "description": "FDA recall Z-2037-2026 — Medline Industries, LP is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A. (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",
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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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2037-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2037-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2037-2026: Medline Industries, LP is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A.",
      "text": "The FDA logged enforcement record Z-2037-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:   1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A;   2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B;   3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A;   4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B;   5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A;   6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A;   7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478;   8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025;   9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030;   10. NEURO, Medline Kit Number/SKU DYNJ902935K;   11. OCULAR, Medline Kit Number/SKU DYNJ909065;   12. OCULAR, Medline Kit Number/SKU DYNJ909065A. — reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-19. Affected lots/codes: Medline Kit Number/SKU DYNJ48725A:  UDI/DI each 10193489853896, UDI/DI case 40193489853897, Lot Number: 24IMG757;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22FME241;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22DMC340;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21JMC829;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21IMC497;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21HMD139;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21GME747;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21FMA440;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21DBU602;  Medline Kit Number/SKU DYNJ64138B:  UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21CBJ936;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23IBC227;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23FBA458;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23DBC239;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23ABI841;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBP260;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBO842;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBN801;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22GBL794;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24HBB998;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24DBQ664;  Medline Kit Number/SKU DYNJ64572A:  UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24CBQ260;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 26ABC645;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25LBB014;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25JBM975;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25HBN493;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25GBM010;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25FBJ206;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25CBN002;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABF979;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABA086;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBE583;  Medline Kit Number/SKU DYNJ64572B:  UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBG667;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25KBQ749;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25JBF743;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25IBA573;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBO985;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBB916;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24GBY148;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24EBO714;  Medline Kit Number/SKU DYNJ67284A:  UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 23LBH320;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBO017;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23JBA275;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23GBK387;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23CBD302;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 26ABF562;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25GBF664;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25EBB838;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25BBQ021;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24LBB454;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24JBE139;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24GBI010;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24FBR965;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24DBQ797;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24BBH448;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23LBL498;  Medline Kit Number/SKU DYNJ81411A:  UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBX879;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23IBE948;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23FBB413;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABN367;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABA089;  Medline Kit Number/SKU DYNJ84478:  UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23KBU302;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25LBL874;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25HBD880;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25EBI919;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBG184;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBF578;  Medline Kit Number/SKU DYNJ85025:  UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24JBS764;  Medline Kit Number/SKU DYNJ89030:  UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25JBH439;  Medline Kit Number/SKU DYNJ89030:  UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25ABP922;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBW005;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBG214;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBP153;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBN621;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBW204;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBE141;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24DBP594;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB058;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB100;  Medline Kit Number/SKU DYNJ902935K:  UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23LBE522;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMB048;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMA495;  Medline Kit Number/SKU DYNJ909065:  UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 22LMD749;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMI877;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMH413;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25GMJ496;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25DMD357;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25AMJ130;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24IME711;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24HME507;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24DMF364;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMI687;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMG984;  Medline Kit Number/SKU DYNJ909065A:  UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24BMI425.. 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-2037-2026&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-2037-2026&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-2037-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2037-2026 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-2037-2026&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-2037-2026&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-2037-2026/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-2037-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2037-2026",
            "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": "During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-03-19",
            "Status": "recorded"
          }
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            "Status": "recorded"
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          "item": {
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            "Value": "Worldwide distribution.",
            "Status": "recorded"
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}