{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
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    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2312-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Model Number: DYNJ63343G;       q. EVLT SURGICAL PACK, Model Number: DYNJ48520;       r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q;       s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C;       t. FLAP HARVEST PACK, Model Number: DYNJ58575B;       u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O;       v. FREE FLAP, Model Number: DYNJ905634B;       w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290;       x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K;       y. FREE FLAP BASIN PACK, Model Number: DYNJ69914;       z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A;       aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K;       cc. GENERAL ANGIO PACK, Model Number: DYNJ57760;       dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M;       ee. HILLCREST PCNL PACK, Model Number: DYNJ69204;       ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B;       gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A;       hh. LAP CHOLE PACK, Model Number: DYNJ41208D;       ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B;       jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A;       kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A;       ll. MINOR, Model Number: DYNJ906915;       mm. MINOR CV, Model Number: DYNJ69898A;       nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418;       oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A;       pp. PCNL PACK, Model Number: DYNJ0569950Q;       qq. PLANO DIEP PACK, Model Number: DYNJ81751;       rr. PORT PACK, Model Number: DYNJ61747C;       ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C;       tt. PV MINOR PACK, Model Number: DYNJ63879D;       uu. RF PACK, Model Number: DYNJ52505A;       vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C;       ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F;       xx. ROBOTIC-LF, Model Number: DYNJ904254F;       yy. ROBOTICS GYN, Model Number: DYNJ905824D;       zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A;       aaa. TAA AAA, Model Number: DYNJ63339C;      bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B;      ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;",
  "description": "FDA recall Z-2312-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Model Number: DYNJ63343G;       q. EVLT SURGICAL PACK, Model Number: DYNJ48520;       r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q;       s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C;       t. FLAP HARVEST PACK, Model Number: DYNJ58575B;       u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O;       v. FREE FLAP, Model Number: DYNJ905634B;       w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290;       x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K;       y. FREE FLAP BASIN PACK, Model Number: DYNJ69914;       z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A;       aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K;       cc. GENERAL ANGIO PACK, Model Number: DYNJ57760;       dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M;       ee. HILLCREST PCNL PACK, Model Number: DYNJ69204;       ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B;       gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A;       hh. LAP CHOLE PACK, Model Number: DYNJ41208D;       ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B;       jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A;       kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A;       ll. MINOR, Model Number: DYNJ906915;       mm. MINOR CV, Model Number: DYNJ69898A;       nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418;       oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A;       pp. PCNL PACK, Model Number: DYNJ0569950Q;       qq. PLANO DIEP PACK, Model Number: DYNJ81751;       rr. PORT PACK, Model Number: DYNJ61747C;       ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C;       tt. PV MINOR PACK, Model Number: DYNJ63879D;       uu. RF PACK, Model Number: DYNJ52505A;       vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C;       ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F;       xx. ROBOTIC-LF, Model Number: DYNJ904254F;       yy. ROBOTICS GYN, Model Number: DYNJ905824D;       zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A;       aaa. TAA AAA, Model Number: DYNJ63339C;      bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B;      ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D; (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",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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-2312-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Model Number: DYNJ63343G;       q. EVLT SURGICAL PACK, Model Number: DYNJ48520;       r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q;       s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C;       t. FLAP HARVEST PACK, Model Number: DYNJ58575B;       u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O;       v. FREE FLAP, Model Number: DYNJ905634B;       w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290;       x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K;       y. FREE FLAP BASIN PACK, Model Number: DYNJ69914;       z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A;       aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K;       cc. GENERAL ANGIO PACK, Model Number: DYNJ57760;       dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M;       ee. HILLCREST PCNL PACK, Model Number: DYNJ69204;       ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B;       gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A;       hh. LAP CHOLE PACK, Model Number: DYNJ41208D;       ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B;       jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A;       kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A;       ll. MINOR, Model Number: DYNJ906915;       mm. MINOR CV, Model Number: DYNJ69898A;       nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418;       oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A;       pp. PCNL PACK, Model Number: DYNJ0569950Q;       qq. PLANO DIEP PACK, Model Number: DYNJ81751;       rr. PORT PACK, Model Number: DYNJ61747C;       ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C;       tt. PV MINOR PACK, Model Number: DYNJ63879D;       uu. RF PACK, Model Number: DYNJ52505A;       vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C;       ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F;       xx. ROBOTIC-LF, Model Number: DYNJ904254F;       yy. ROBOTICS GYN, Model Number: DYNJ905824D;       zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A;       aaa. TAA AAA, Model Number: DYNJ63339C;      bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B;      ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2312-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2312-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Model Number: DYNJ63343G;       q. EVLT SURGICAL PACK, Model Number: DYNJ48520;       r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q;       s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C;       t. FLAP HARVEST PACK, Model Number: DYNJ58575B;       u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O;       v. FREE FLAP, Model Number: DYNJ905634B;       w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290;       x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K;       y. FREE FLAP BASIN PACK, Model Number: DYNJ69914;       z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A;       aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K;       cc. GENERAL ANGIO PACK, Model Number: DYNJ57760;       dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M;       ee. HILLCREST PCNL PACK, Model Number: DYNJ69204;       ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B;       gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A;       hh. LAP CHOLE PACK, Model Number: DYNJ41208D;       ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B;       jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A;       kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A;       ll. MINOR, Model Number: DYNJ906915;       mm. MINOR CV, Model Number: DYNJ69898A;       nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418;       oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A;       pp. PCNL PACK, Model Number: DYNJ0569950Q;       qq. PLANO DIEP PACK, Model Number: DYNJ81751;       rr. PORT PACK, Model Number: DYNJ61747C;       ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C;       tt. PV MINOR PACK, Model Number: DYNJ63879D;       uu. RF PACK, Model Number: DYNJ52505A;       vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C;       ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F;       xx. ROBOTIC-LF, Model Number: DYNJ904254F;       yy. ROBOTICS GYN, Model Number: DYNJ905824D;       zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A;       aaa. TAA AAA, Model Number: DYNJ63339C;      bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B;      ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;",
      "text": "The FDA logged enforcement record Z-2312-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Model Number: DYNJ63343G;       q. EVLT SURGICAL PACK, Model Number: DYNJ48520;       r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q;       s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C;       t. FLAP HARVEST PACK, Model Number: DYNJ58575B;       u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O;       v. FREE FLAP, Model Number: DYNJ905634B;       w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290;       x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K;       y. FREE FLAP BASIN PACK, Model Number: DYNJ69914;       z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A;       aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B;       bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K;       cc. GENERAL ANGIO PACK, Model Number: DYNJ57760;       dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M;       ee. HILLCREST PCNL PACK, Model Number: DYNJ69204;       ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B;       gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A;       hh. LAP CHOLE PACK, Model Number: DYNJ41208D;       ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B;       jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A;       kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A;       ll. MINOR, Model Number: DYNJ906915;       mm. MINOR CV, Model Number: DYNJ69898A;       nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418;       oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A;       pp. PCNL PACK, Model Number: DYNJ0569950Q;       qq. PLANO DIEP PACK, Model Number: DYNJ81751;       rr. PORT PACK, Model Number: DYNJ61747C;       ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C;       tt. PV MINOR PACK, Model Number: DYNJ63879D;       uu. RF PACK, Model Number: DYNJ52505A;       vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C;       ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F;       xx. ROBOTIC-LF, Model Number: DYNJ904254F;       yy. ROBOTICS GYN, Model Number: DYNJ905824D;       zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A;       aaa. TAA AAA, Model Number: DYNJ63339C;      bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B;      ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D; — reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-15. Affected lots/codes: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ40629B, UPC Number: 088827777869.   b. Model Number: DYNJ81410B, UPC Number: 019532732082.   c. Model Number: DYNJ901145G, UPC Number: 019348985021.   d. Model Number: DYNJC9299M, UPC Number: 019348926312; Model Number: DYNJC9299O, UPC Number: 019532718840.   e. Model Number: DYNJ24459P, UPC Number: 019348935534.   f. Model Number: DYNJ36242, UPC Number: 088438951744.   g. Model Number: DYNJ60667C, UPC Number: 019348940759; Model Number: DYNJ60667D, UPC Number: 019348986151; Model Number: DYNJ60667F, UPC Number: 019532702361; Model Number: DYNJ83942, UPC Number: 019532731798.   h. Model Number: DYNJ905761A, UPC Number: 019348946321.   i. Model Number: DYNJ68447B, UPC Number: 019532703416.   j. Model Number: DYNJ69204A, UPC Number: 019532711427.   k. Model Number: DYNJ901296B, UPC Number: 019348992335.   l. Model Number: DYNJ66867A, UPC Number: 019348998623.   m. Model Number: DYNJ0426069N, UPC Number: 019532737131.   n. Model Number: DYNJ82517, UPC Number: 019532719864.   o. Model Number: DYNJ44210B, UPC Number: 019348930685.   p. Model Number: DYNJ63343G, UPC Number: 019532727346.   q. Model Number: DYNJ48520, UPC Number: 088827790346.    r. Model Number: CDS840214Q, UPC Number: 019532728990.   s. Model Number: DYNJ907076A, UPC Number: 019348938164; Model Number: DYNJ907076B, UPC Number: 019348945045; Model Number: DYNJ907076C, UPC Number: 019348946561.   t. Model Number: DYNJ58575B, UPC Number: 019348989550.   u. Model Number: DYNJ0378388O, UPC Number: 019348956435.   v. Model Number: DYNJ905634B, UPC Number: 019348963392.   w. Model Number: DYNJ80290, UPC Number: 019532703724.   x. Model Number: DYNJ0991320K, UPC Number: 019348956435.   y. Model Number: DYNJ69914, UPC Number: 019348999641.   z. Model Number: DYNJ68447, UPC Number: 019348944709; Model Number: DYNJ68447A, UPC Number: 019348991380.   aa. Model Number: DYNJ68380, UPC Number: 019348943974; Model Number: DYNJ68380A, UPC Number: 019348991319; Model Number: DYNJ68380B, UPC Number: 019532703378.   bb. Model Number: DYNJ0049595C, UPC Number: 019348980698; Model Number: DYNJ20495K, UPC Number: 019532737078.   cc. Model Number: DYNJ57760, UPC Number: 088994277494.   dd. Model Number: CDS982779L, UPC Number: 019348963341; Model Number: CDS982779M, UPC Number: 019348944627.   ee. Model Number: DYNJ69204, UPC Number: 019348990830.   ff. Model Number: DYNJ905366A, UPC Number: 019348975937; Model Number: DYNJ905366B, UPC Number: 019532704806.   gg. Model Number: DYKMBNDL54A, UPC Number: 019532704487.   hh. Model Number: DYNJ41208D, UPC Number: 019348929718.    ii. Model Number: DYNJ80172, UPC Number: 019532701341; Model Number: DYNJ80172A, UPC Number: 019532712324; Model Number: DYNJ80172B, UPC Number: 019532735918.   jj. Model Number: DYNJ68172A, UPC Number: 019348997493.   kk. Model Number: DYNJ53059A, UPC Number: 088994241511.   ll. Model Number: DYNJ906915, UPC Number: 019348928037.   mm. Model Number: DYNJ69898A, UPC Number: 019532723505.   nn. Model Number: DYNDA2418, UPC Number: 019348937821.   oo. Model Number: DYNJ60242A, UPC Number: 019348924698.   pp. Model Number: DYNJ0569950Q, UPC Number: 019348978281.   qq. Model Number: DYNJ81751, UPC Number: 019532713931.   rr. Model Number: DYNJ61747C, UPC Number: 019348936503.   ss. Model Number: DYNJ908046C, UPC Number: 019532731349.   tt. Model Number: DYNJ63879D, UPC Number: 019532722189.   uu. Model Number: DYNJ52505A, UPC Number: 019348972485.   vv. Model Number: DYNJ904219G, UPC Number: 019348948513; Model Number: DYNJ904343C, UPC Number: 019348982294.   ww. Model Number: DYNJ904250F, UPC Number: 019348981399.   xx. Model Number: DYNJ904254F, UPC Number: 019348945242.   yy. Model Number: DYNJ905824D, UPC Number: 019348986150.   zz. Model Number: DYNJRA0961A, UPC Number: 019348926312.   aaa. Model Number: DYNJ63339C, UPC Number: 019348995807.   bbb. Model Number: DYNJ41927B, UPC Number: 088994242830.   ccc. Model Number: PHS751646C, UPC Number: 088994224535; Model Number: PHS751646D, UPC Number: 019532719680.. 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-2312-2023&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-2312-2023&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-2312-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2312-2023 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-2312-2023&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-2312-2023&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-2312-2023/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-2312-2023",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2312-2023",
            "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 - Northfield",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-15",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:    a. Model Number: DYNJ40629B, UPC Number: 088827777869.   b. Model Number: DYNJ81410B, UPC Number: 019532732082.   c. Model Number: DYNJ901145G, UPC Number: 019348985021.   d. Model Number: DYNJC9299M, UPC Number: 019348926312; Model Number: DYNJC9299O, UPC Number: 019532718840.   e. Model Number: DYNJ24459P, UPC Number: 019348935534.   f. Model Number: DYNJ36242, UPC Number: 088438951744.   g. Model Number: DYNJ60667C, UPC Number: 019348940759; Model Number: DYNJ60667D, UPC Number: 019348986151; Model Number: DYNJ60667F, UPC Number: 019532702361; Model Number: DYNJ83942, UPC Number: 019532731798.   h. Model Number: DYNJ905761A, UPC Number: 019348946321.   i. Model Number: DYNJ68447B, UPC Number: 019532703416.   j. Model Number: DYNJ69204A, UPC Number: 019532711427.   k. Model Number: DYNJ901296B, UPC Number: 019348992335.   l. Model Number: DYNJ66867A, UPC Number: 019348998623.   m. Model Number: DYNJ0426069N, UPC Number: 019532737131.   n. Model Number: DYNJ82517, UPC Number: 019532719864.   o. Model Number: DYNJ44210B, UPC Number: 019348930685.   p. Model Number: DYNJ63343G, UPC Number: 019532727346.   q. Model Number: DYNJ48520, UPC Number: 088827790346.    r. Model Number: CDS840214Q, UPC Number: 019532728990.   s. Model Number: DYNJ907076A, UPC Number: 019348938164; Model Number: DYNJ907076B, UPC Number: 019348945045; Model Number: DYNJ907076C, UPC Number: 019348946561.   t. Model Number: DYNJ58575B, UPC Number: 019348989550.   u. Model Number: DYNJ0378388O, UPC Number: 019348956435.   v. Model Number: DYNJ905634B, UPC Number: 019348963392.   w. Model Number: DYNJ80290, UPC Number: 019532703724.   x. Model Number: DYNJ0991320K, UPC Number: 019348956435.   y. Model Number: DYNJ69914, UPC Number: 019348999641.   z. Model Number: DYNJ68447, UPC Number: 019348944709; Model Number: DYNJ68447A, UPC Number: 019348991380.   aa. Model Number: DYNJ68380, UPC Number: 019348943974; Model Number: DYNJ68380A, UPC Number: 019348991319; Model Number: DYNJ68380B, UPC Number: 019532703378.   bb. Model Number: DYNJ0049595C, UPC Number: 019348980698; Model Number: DYNJ20495K, UPC Number: 019532737078.   cc. Model Number: DYNJ57760, UPC Number: 088994277494.   dd. Model Number: CDS982779L, UPC Number: 019348963341; Model Number: CDS982779M, UPC Number: 019348944627.   ee. Model Number: DYNJ69204, UPC Number: 019348990830.   ff. Model Number: DYNJ905366A, UPC Number: 019348975937; Model Number: DYNJ905366B, UPC Number: 019532704806.   gg. Model Number: DYKMBNDL54A, UPC Number: 019532704487.   hh. Model Number: DYNJ41208D, UPC Number: 019348929718.    ii. Model Number: DYNJ80172, UPC Number: 019532701341; Model Number: DYNJ80172A, UPC Number: 019532712324; Model Number: DYNJ80172B, UPC Number: 019532735918.   jj. Model Number: DYNJ68172A, UPC Number: 019348997493.   kk. Model Number: DYNJ53059A, UPC Number: 088994241511.   ll. Model Number: DYNJ906915, UPC Number: 019348928037.   mm. Model Number: DYNJ69898A, UPC Number: 019532723505.   nn. Model Number: DYNDA2418, UPC Number: 019348937821.   oo. Model Number: DYNJ60242A, UPC Number: 019348924698.   pp. Model Number: DYNJ0569950Q, UPC Number: 019348978281.   qq. Model Number: DYNJ81751, UPC Number: 019532713931.   rr. Model Number: DYNJ61747C, UPC Number: 019348936503.   ss. Model Number: DYNJ908046C, UPC Number: 019532731349.   tt. Model Number: DYNJ63879D, UPC Number: 019532722189.   uu. Model Number: DYNJ52505A, UPC Number: 019348972485.   vv. Model Number: DYNJ904219G, UPC Number: 019348948513; Model Number: DYNJ904343C, UPC Number: 019348982294.   ww. Model Number: DYNJ904250F, UPC Number: 019348981399.   xx. Model Number: DYNJ904254F, UPC Number: 019348945242.   yy. Model Number: DYNJ905824D, UPC Number: 019348986150.   zz. Model Number: DYNJRA0961A, UPC Number: 019348926312.   aaa. Model Number: DYNJ63339C, UPC Number: 019348995807.   bbb. Model Number: DYNJ41927B, UPC Number: 088994242830.   ccc. Model Number: PHS751646C, UPC Number: 088994224535; Model Number: PHS751646D, UPC Number: 019532719680.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}