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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1417-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits:  1) C-SECTION PACK, Model Number: CDS820080N;   2) C-SECTION CDS, Model Number: CDS983523G;   3) C-SECTION, Model Number: CDSCCR611O;   4) C-SECTION, Model Number: CDSCCR611P;   5) LUD C-SECTION-LF, Model Number: DYNJ0101616I;   6) C-SECTION TRAY, Model Number: DYNJ15494G;   7) C-SECTION TRAY-LF, Model Number: DYNJ19529P;   8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q;   9) C-SECTION TRAY-LF, Model Number: DYNJ19529R;   10) C-SECTION TRAY-LF, Model Number: DYNJ19529S;   11) C-SECTION PACK-LF, Model Number: DYNJ21550Q;   12) C-SECTION PACK, Model Number: DYNJ23544F;   13) C-SECTION PACK, Model Number: DYNJ32632F;   14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I;   15) C-SECTION PACK-LF, Model Number: DYNJ38801F;   16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C;   17) C-SECTION, Model Number: DYNJ41444F;   18) C-SECTION PACK, Model Number: DYNJ49224I;   19) C SECTION PACK-LF, Model Number: DYNJ52387I;   20) C-SECTION PACK, Model Number: DYNJ56523C;   21) C-SECTION PACK, Model Number: DYNJ59387L;   22) C-SECTION PACK, Model Number: DYNJ64549B;   23) C SECTION PACK, Model Number: DYNJ67347A;   24) C SECTION PACK, Model Number: DYNJ69778A;   25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I;   26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K;   27) PAD C-SECTION, Model Number: DYNJ902134C;   28) RICH C-SECTION, Model Number: DYNJ902182J;   29) C-SECTION PACK, Model Number: DYNJ904329D;   30) C-SECTION, Model Number: DYNJ904697F;   31) KIT C SECTION, Model Number: DYNJ906966G;   32) C SECTION, Model Number: DYNJ907999A;   33) C-SECTION, Model Number: DYNJ909058;   34) C-SECTION PACK, Model Number: DYNJ909507;   35) C SECTION TRAY, Model Number: DYNJT3407;   36) TR-C SECTION PACK-LF, Model Number: PHS583549002B",
  "description": "FDA recall Z-1417-2026 — Medline Industries, LP is recalling Medline Convenience Kits:  1) C-SECTION PACK, Model Number: CDS820080N;   2) C-SECTION CDS, Model Number: CDS983523G;   3) C-SECTION, Model Number: CDSCCR611O;   4) C-SECTION, Model Number: CDSCCR611P;   5) LUD C-SECTION-LF, Model Number: DYNJ0101616I;   6) C-SECTION TRAY, Model Number: DYNJ15494G;   7) C-SECTION TRAY-LF, Model Number: DYNJ19529P;   8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q;   9) C-SECTION TRAY-LF, Model Number: DYNJ19529R;   10) C-SECTION TRAY-LF, Model Number: DYNJ19529S;   11) C-SECTION PACK-LF, Model Number: DYNJ21550Q;   12) C-SECTION PACK, Model Number: DYNJ23544F;   13) C-SECTION PACK, Model Number: DYNJ32632F;   14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I;   15) C-SECTION PACK-LF, Model Number: DYNJ38801F;   16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C;   17) C-SECTION, Model Number: DYNJ41444F;   18) C-SECTION PACK, Model Number: DYNJ49224I;   19) C SECTION PACK-LF, Model Number: DYNJ52387I;   20) C-SECTION PACK, Model Number: DYNJ56523C;   21) C-SECTION PACK, Model Number: DYNJ59387L;   22) C-SECTION PACK, Model Number: DYNJ64549B;   23) C SECTION PACK, Model Number: DYNJ67347A;   24) C SECTION PACK, Model Number: DYNJ69778A;   25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I;   26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K;   27) PAD C-SECTION, Model Number: DYNJ902134C;   28) RICH C-SECTION, Model Number: DYNJ902182J;   29) C-SECTION PACK, Model Number: DYNJ904329D;   30) C-SECTION, Model Number: DYNJ904697F;   31) KIT C SECTION, Model Number: DYNJ906966G;   32) C SECTION, Model Number: DYNJ907999A;   33) C-SECTION, Model Number: DYNJ909058;   34) C-SECTION PACK, Model Number: DYNJ909507;   35) C SECTION TRAY, Model Number: DYNJT3407;   36) TR-C SECTION PACK-LF, Model Number: PHS583549002B (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"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1417-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits:  1) C-SECTION PACK, Model Number: CDS820080N;   2) C-SECTION CDS, Model Number: CDS983523G;   3) C-SECTION, Model Number: CDSCCR611O;   4) C-SECTION, Model Number: CDSCCR611P;   5) LUD C-SECTION-LF, Model Number: DYNJ0101616I;   6) C-SECTION TRAY, Model Number: DYNJ15494G;   7) C-SECTION TRAY-LF, Model Number: DYNJ19529P;   8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q;   9) C-SECTION TRAY-LF, Model Number: DYNJ19529R;   10) C-SECTION TRAY-LF, Model Number: DYNJ19529S;   11) C-SECTION PACK-LF, Model Number: DYNJ21550Q;   12) C-SECTION PACK, Model Number: DYNJ23544F;   13) C-SECTION PACK, Model Number: DYNJ32632F;   14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I;   15) C-SECTION PACK-LF, Model Number: DYNJ38801F;   16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C;   17) C-SECTION, Model Number: DYNJ41444F;   18) C-SECTION PACK, Model Number: DYNJ49224I;   19) C SECTION PACK-LF, Model Number: DYNJ52387I;   20) C-SECTION PACK, Model Number: DYNJ56523C;   21) C-SECTION PACK, Model Number: DYNJ59387L;   22) C-SECTION PACK, Model Number: DYNJ64549B;   23) C SECTION PACK, Model Number: DYNJ67347A;   24) C SECTION PACK, Model Number: DYNJ69778A;   25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I;   26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K;   27) PAD C-SECTION, Model Number: DYNJ902134C;   28) RICH C-SECTION, Model Number: DYNJ902182J;   29) C-SECTION PACK, Model Number: DYNJ904329D;   30) C-SECTION, Model Number: DYNJ904697F;   31) KIT C SECTION, Model Number: DYNJ906966G;   32) C SECTION, Model Number: DYNJ907999A;   33) C-SECTION, Model Number: DYNJ909058;   34) C-SECTION PACK, Model Number: DYNJ909507;   35) C SECTION TRAY, Model Number: DYNJT3407;   36) TR-C SECTION PACK-LF, Model Number: PHS583549002B",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1417-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1417-2026: Medline Industries, LP is recalling Medline Convenience Kits:  1) C-SECTION PACK, Model Number: CDS820080N;   2) C-SECTION CDS, Model Number: CDS983523G;   3) C-SECTION, Model Number: CDSCCR611O;   4) C-SECTION, Model Number: CDSCCR611P;   5) LUD C-SECTION-LF, Model Number: DYNJ0101616I;   6) C-SECTION TRAY, Model Number: DYNJ15494G;   7) C-SECTION TRAY-LF, Model Number: DYNJ19529P;   8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q;   9) C-SECTION TRAY-LF, Model Number: DYNJ19529R;   10) C-SECTION TRAY-LF, Model Number: DYNJ19529S;   11) C-SECTION PACK-LF, Model Number: DYNJ21550Q;   12) C-SECTION PACK, Model Number: DYNJ23544F;   13) C-SECTION PACK, Model Number: DYNJ32632F;   14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I;   15) C-SECTION PACK-LF, Model Number: DYNJ38801F;   16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C;   17) C-SECTION, Model Number: DYNJ41444F;   18) C-SECTION PACK, Model Number: DYNJ49224I;   19) C SECTION PACK-LF, Model Number: DYNJ52387I;   20) C-SECTION PACK, Model Number: DYNJ56523C;   21) C-SECTION PACK, Model Number: DYNJ59387L;   22) C-SECTION PACK, Model Number: DYNJ64549B;   23) C SECTION PACK, Model Number: DYNJ67347A;   24) C SECTION PACK, Model Number: DYNJ69778A;   25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I;   26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K;   27) PAD C-SECTION, Model Number: DYNJ902134C;   28) RICH C-SECTION, Model Number: DYNJ902182J;   29) C-SECTION PACK, Model Number: DYNJ904329D;   30) C-SECTION, Model Number: DYNJ904697F;   31) KIT C SECTION, Model Number: DYNJ906966G;   32) C SECTION, Model Number: DYNJ907999A;   33) C-SECTION, Model Number: DYNJ909058;   34) C-SECTION PACK, Model Number: DYNJ909507;   35) C SECTION TRAY, Model Number: DYNJT3407;   36) TR-C SECTION PACK-LF, Model Number: PHS583549002B",
      "text": "The FDA logged enforcement record Z-1417-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits:  1) C-SECTION PACK, Model Number: CDS820080N;   2) C-SECTION CDS, Model Number: CDS983523G;   3) C-SECTION, Model Number: CDSCCR611O;   4) C-SECTION, Model Number: CDSCCR611P;   5) LUD C-SECTION-LF, Model Number: DYNJ0101616I;   6) C-SECTION TRAY, Model Number: DYNJ15494G;   7) C-SECTION TRAY-LF, Model Number: DYNJ19529P;   8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q;   9) C-SECTION TRAY-LF, Model Number: DYNJ19529R;   10) C-SECTION TRAY-LF, Model Number: DYNJ19529S;   11) C-SECTION PACK-LF, Model Number: DYNJ21550Q;   12) C-SECTION PACK, Model Number: DYNJ23544F;   13) C-SECTION PACK, Model Number: DYNJ32632F;   14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I;   15) C-SECTION PACK-LF, Model Number: DYNJ38801F;   16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C;   17) C-SECTION, Model Number: DYNJ41444F;   18) C-SECTION PACK, Model Number: DYNJ49224I;   19) C SECTION PACK-LF, Model Number: DYNJ52387I;   20) C-SECTION PACK, Model Number: DYNJ56523C;   21) C-SECTION PACK, Model Number: DYNJ59387L;   22) C-SECTION PACK, Model Number: DYNJ64549B;   23) C SECTION PACK, Model Number: DYNJ67347A;   24) C SECTION PACK, Model Number: DYNJ69778A;   25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I;   26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K;   27) PAD C-SECTION, Model Number: DYNJ902134C;   28) RICH C-SECTION, Model Number: DYNJ902182J;   29) C-SECTION PACK, Model Number: DYNJ904329D;   30) C-SECTION, Model Number: DYNJ904697F;   31) KIT C SECTION, Model Number: DYNJ906966G;   32) C SECTION, Model Number: DYNJ907999A;   33) C-SECTION, Model Number: DYNJ909058;   34) C-SECTION PACK, Model Number: DYNJ909507;   35) C SECTION TRAY, Model Number: DYNJT3407;   36) TR-C SECTION PACK-LF, Model Number: PHS583549002B — reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-07. Affected lots/codes: 1) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 16) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 17) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 18) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 19) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 20) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 21) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 22) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 23) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 24) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 25) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 26) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 27) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 28) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 29) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 30) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 31) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 32) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 33) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 34) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 35) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 36) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 37) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 38) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 39) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 40) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 41) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 42) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 43) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 44) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 45) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 46) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 47) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 48) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 49) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 50) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 51) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 52) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 53) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 54) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 55) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 56) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21IBL808; 57) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21GBB842; 58) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBS046; 59) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBQ743; 60) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21BBF750; 61) DYNJ904329D, UDI-DI: 10198459221071(each), 40198459221072(case), Lot Number: 25EBJ650; 62) DYNJ904697F, UDI-DI: 10195327169275(each), 40195327169276(case), Lot Number: 22FDA703; 63) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBS185; 64) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBF270; 65) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBV882; 66) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBR695; 67) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24DBN053; 68) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24BBV274; 69) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 22CMH174; 70) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21LMB616; 71) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21JMC590; 72) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23EBP308; 73) DYNJ909507, UDI-DI: 10195327387075(each), 40195327387076(case), Lot Number: 23GME519; 74) DYNJT3407, UDI-DI: 10198459324970(each), 40198459324971(case), Lot Number: 25EBK673; 75) PHS583549002B, UDI-DI: 10193489643558(each), 40193489643559(case), Lot Number: 21ADA554. 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-1417-2026&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-1417-2026&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-1417-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1417-2026 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-1417-2026&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-1417-2026&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-1417-2026/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."
    }
  ],
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      "name": "FDA recall details — Z-1417-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1417-2026",
            "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": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-07",
            "Status": "recorded"
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            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide.",
            "Status": "recorded"
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