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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2017-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.",
  "description": "FDA recall Z-2017-2026 — Medline Industries, LP is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D. (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"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2017-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2017-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2017-2026: Medline Industries, LP is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.",
      "text": "The FDA logged enforcement record Z-2017-2026: Medline Industries, LP is voluntarily recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:    1. VP SHUNT, Medline Kit Number/SKU CDS840193V;   2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J;   3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G;   4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K;   5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L;   6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F;   7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B;   8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D;   9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C;   10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G;   11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A;   12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C;   13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F;   14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501;   15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D. — 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 CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBW804;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBX015;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBD094;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23IBQ501;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23FBO564;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23EBW686;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23DBO524;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22GBU281;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBR456;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBM213;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBN031;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22DBP331;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22MBA145;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22ABM907;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21KBE066;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21JBE527;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBH244;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE520;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE521;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21FBC630;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22IBU058;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22HBH306;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22GBQ912;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBT185;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBI063;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21IBM934;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21GBN290;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21DBG187;  Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21IBP593;  Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21HBA351;  Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBE684;  Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBA846;  Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21FBI072;  Medline Kit Number/SKU DYNJ04592K: UDI/DI each 10193489215205, UDI/DI case 40193489215206, Lot Number : 23JLA230;  Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 22FBH340;  Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21CKA561;  Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21BKA591;  Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21AKB149;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23KBE105;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23JBH870;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23IBS256;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23HBW099;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23EBB384;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 22JBP897;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABI491;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABG881;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABH208;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABF236;  Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABB836;  Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21KMH013;  Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JME705;  Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JMD611;  Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21IME971;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26BME412;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26AMJ494;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25KMG940;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25GMH433;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23KBN958;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23JBH478;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23HBT146;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23GBG624;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23CBC001;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABU575;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABL787;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBM663;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBJ926;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22JBG520;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22IBR340;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22EBU759;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22DBR774;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ813;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ792;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21KBG387;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21IBR350;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21GBV108;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21FBJ559;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21DBE602;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21CBJ874;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBI620;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBA242;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25JBD488;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25HBM158;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25GBE204;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25EBR912;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25BBU542;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25ABW421;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24KBO504;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24JBM902;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24IBK100;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24GBE540;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24FBK645;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24DBS967;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24BBG984;  Medline Kit Number/SKU DYNJ56819G: UDI/DI each 10195327073749, UDI/DI case 40195327073740, Lot Number : 22HBB961;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21KLA936;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21JLA574;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21HLA401;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLB120;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA452;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA295;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21CLA652;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23IMI021;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24HMA726;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24GMI771;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24DMB264;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23KMJ671;  Medline Kit Number/SKU DYNJ68213F: UDI/DI each 10198459501173, UDI/DI case 40198459501174, Lot Number : 25IMD349;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23GBI579;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 24ABL755;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23LBC527;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22CDC077;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADC035;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADB161;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADA979;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21LDA084;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21HDB299;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21DDC112;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21ADC003.. 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-2017-2026&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-2017-2026&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-2017-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2017-2026 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-2017-2026&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-2017-2026&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-2017-2026/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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      "name": "FDA recall details — Z-2017-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2017-2026",
            "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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          "item": {
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 Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBM213;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBN031;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22DBP331;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22MBA145;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22ABM907;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21KBE066;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21JBE527;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBH244;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE520;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE521;  Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21FBC630;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22IBU058;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22HBH306;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22GBQ912;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBT185;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBI063;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21IBM934;  Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21GBN290; 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 Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26AMJ494;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25KMG940;  Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25GMH433;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23KBN958;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23JBH478;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23HBT146;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23GBG624;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23CBC001;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABU575;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABL787;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBM663;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBJ926;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22JBG520;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22IBR340;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22EBU759;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22DBR774;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ813;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ792;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21KBG387;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21IBR350;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21GBV108;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21FBJ559;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21DBE602;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21CBJ874;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBI620;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBA242;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25JBD488;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25HBM158;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25GBE204;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25EBR912;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25BBU542;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25ABW421;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24KBO504;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24JBM902;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24IBK100;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24GBE540;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24FBK645;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24DBS967;  Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24BBG984;  Medline Kit Number/SKU DYNJ56819G: UDI/DI each 10195327073749, UDI/DI case 40195327073740, Lot Number : 22HBB961;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21KLA936;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21JLA574;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21HLA401;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLB120;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA452;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA295;  Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21CLA652;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23IMI021;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24HMA726;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24GMI771;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24DMB264;  Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23KMJ671;  Medline Kit Number/SKU DYNJ68213F: UDI/DI each 10198459501173, UDI/DI case 40198459501174, Lot Number : 25IMD349;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23GBI579;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 24ABL755;  Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23LBC527;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22CDC077;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADC035;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADB161;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADA979;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21LDA084;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21HDB299;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21DDC112;  Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21ADC003.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}