{
  "@context": {
    "schema": "https://schema.org/",
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      "@id": "au:claims",
      "@container": "@list"
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    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
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    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
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    "commercialInfluence": "au:commercialInfluence",
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0833-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Custom procedural convenience kits and trays, Othopedic use, labeled as:    a)\tHIP FRACTURE, kit number AHHF15C;   b)\tHIP FRACTURE, kit number AHHF15D;   c)\tHand Pack, kit number BBHP10E;   d)\tLower Extremity, kit number BBLE40B;   e)\tCustom Podiatry, kit number BOCP70J;   f)\tROBOTIC PACK, kit number BPAR65A;   g)\tHIP PINNING PACK, kit number EMHP84;   h)\tHIP PINNING PK, STRL F G, kit number FHHI17V;   i)\tTOTAL HIP PACK, kit number GNTH06L;   j)\tTOTAL KNEE PACK, kit number GNTK07L;   k)\tEXTREMITY PACK, kit number GUEX48I;   l)\tMAJOR ORTHO PACK, kit number GUMO40J;   m)\tTOTAL KNEE ACCESS PACK, kit number HITK58D;   n)\tSHOULDER ARTHROSCOPY, kit number HNSH17H;   o)\tTOTAL HIP PACK, kit number HNTH76M;   p)\tTOTAL KNEE PACK, kit number HNTK81M;   q)\tORIF HIP PACK, kit number HOHP28;   r)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S;   s)\tCustom Lower Ext, kit number JSLE08E;   t)\tHAND PACK, kit number LVHD29;   u)\tKIT, LOWER EXTREMITY, kit number MMEX19E;   v)\tKIT, HIP PINNING, kit number MMHP45E;   w)\tKIT, ORTHO SPINE, kit number MMSP21H;   x)\tKIT, TOTAL HIP, kit number MMTH15E;   y)\tKIT, TOTAL KNEE, kit number MMTK66E;   z)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E;   aa)\tHIP SCOPE, kit number PTHS10D;   bb)\tHIP SCOPE, kit number PTHS10F;   cc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D;   dd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F;   ee)\tTOTAL ORTHO SAH, kit number SATO27F;   ff)\tTOTAL ORTHO SAH, kit number SATO27G;   gg)\tPODIATRY PACK, kit number SMPD35;   hh)\tSHOULDER PACK, kit number SMSH12;   ii)\tMAJOR SETUP PACK, kit number SMSU17A;   jj)\tTOTAL HIP, kit number SMTH39;   kk)\tTOTAL KNEE, kit number SMTK21;   ll)\tKnee Arthroscopy, kit number SPKA57Q;   mm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P;   nn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF;   oo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF;   pp)\tUPPER EXTREMITY, kit number SRUE05M;   qq)\tArthroscopy Pack, kit number THAR35B;   rr)\tExtremity Pack, kit number THEX27B  ss)\tShoulder Pack, kit number THSH07F  tt)\tTotal Joint, kit number THTJ22G  uu)\tTOTAL HIP PACK, kit number WHTH07D  vv)\tTOTAL HIP PACK, kit number WHTH07E  ww)\tTOTAL KNEE, kit number WHTK06C  xx)\tTOTAL KNEE, kit number WHTK06D  yy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E",
  "description": "FDA recall Z-0833-2024 — American Contract Systems, Inc. is recalling Custom procedural convenience kits and trays, Othopedic use, labeled as:    a)\tHIP FRACTURE, kit number AHHF15C;   b)\tHIP FRACTURE, kit number AHHF15D;   c)\tHand Pack, kit number BBHP10E;   d)\tLower Extremity, kit number BBLE40B;   e)\tCustom Podiatry, kit number BOCP70J;   f)\tROBOTIC PACK, kit number BPAR65A;   g)\tHIP PINNING PACK, kit number EMHP84;   h)\tHIP PINNING PK, STRL F G, kit number FHHI17V;   i)\tTOTAL HIP PACK, kit number GNTH06L;   j)\tTOTAL KNEE PACK, kit number GNTK07L;   k)\tEXTREMITY PACK, kit number GUEX48I;   l)\tMAJOR ORTHO PACK, kit number GUMO40J;   m)\tTOTAL KNEE ACCESS PACK, kit number HITK58D;   n)\tSHOULDER ARTHROSCOPY, kit number HNSH17H;   o)\tTOTAL HIP PACK, kit number HNTH76M;   p)\tTOTAL KNEE PACK, kit number HNTK81M;   q)\tORIF HIP PACK, kit number HOHP28;   r)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S;   s)\tCustom Lower Ext, kit number JSLE08E;   t)\tHAND PACK, kit number LVHD29;   u)\tKIT, LOWER EXTREMITY, kit number MMEX19E;   v)\tKIT, HIP PINNING, kit number MMHP45E;   w)\tKIT, ORTHO SPINE, kit number MMSP21H;   x)\tKIT, TOTAL HIP, kit number MMTH15E;   y)\tKIT, TOTAL KNEE, kit number MMTK66E;   z)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E;   aa)\tHIP SCOPE, kit number PTHS10D;   bb)\tHIP SCOPE, kit number PTHS10F;   cc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D;   dd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F;   ee)\tTOTAL ORTHO SAH, kit number SATO27F;   ff)\tTOTAL ORTHO SAH, kit number SATO27G;   gg)\tPODIATRY PACK, kit number SMPD35;   hh)\tSHOULDER PACK, kit number SMSH12;   ii)\tMAJOR SETUP PACK, kit number SMSU17A;   jj)\tTOTAL HIP, kit number SMTH39;   kk)\tTOTAL KNEE, kit number SMTK21;   ll)\tKnee Arthroscopy, kit number SPKA57Q;   mm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P;   nn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF;   oo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF;   pp)\tUPPER EXTREMITY, kit number SRUE05M;   qq)\tArthroscopy Pack, kit number THAR35B;   rr)\tExtremity Pack, kit number THEX27B  ss)\tShoulder Pack, kit number THSH07F  tt)\tTotal Joint, kit number THTJ22G  uu)\tTOTAL HIP PACK, kit number WHTH07D  vv)\tTOTAL HIP PACK, kit number WHTH07E  ww)\tTOTAL KNEE, kit number WHTK06C  xx)\tTOTAL KNEE, kit number WHTK06D  yy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E (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"
    }
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0833-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Custom procedural convenience kits and trays, Othopedic use, labeled as:    a)\tHIP FRACTURE, kit number AHHF15C;   b)\tHIP FRACTURE, kit number AHHF15D;   c)\tHand Pack, kit number BBHP10E;   d)\tLower Extremity, kit number BBLE40B;   e)\tCustom Podiatry, kit number BOCP70J;   f)\tROBOTIC PACK, kit number BPAR65A;   g)\tHIP PINNING PACK, kit number EMHP84;   h)\tHIP PINNING PK, STRL F G, kit number FHHI17V;   i)\tTOTAL HIP PACK, kit number GNTH06L;   j)\tTOTAL KNEE PACK, kit number GNTK07L;   k)\tEXTREMITY PACK, kit number GUEX48I;   l)\tMAJOR ORTHO PACK, kit number GUMO40J;   m)\tTOTAL KNEE ACCESS PACK, kit number HITK58D;   n)\tSHOULDER ARTHROSCOPY, kit number HNSH17H;   o)\tTOTAL HIP PACK, kit number HNTH76M;   p)\tTOTAL KNEE PACK, kit number HNTK81M;   q)\tORIF HIP PACK, kit number HOHP28;   r)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S;   s)\tCustom Lower Ext, kit number JSLE08E;   t)\tHAND PACK, kit number LVHD29;   u)\tKIT, LOWER EXTREMITY, kit number MMEX19E;   v)\tKIT, HIP PINNING, kit number MMHP45E;   w)\tKIT, ORTHO SPINE, kit number MMSP21H;   x)\tKIT, TOTAL HIP, kit number MMTH15E;   y)\tKIT, TOTAL KNEE, kit number MMTK66E;   z)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E;   aa)\tHIP SCOPE, kit number PTHS10D;   bb)\tHIP SCOPE, kit number PTHS10F;   cc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D;   dd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F;   ee)\tTOTAL ORTHO SAH, kit number SATO27F;   ff)\tTOTAL ORTHO SAH, kit number SATO27G;   gg)\tPODIATRY PACK, kit number SMPD35;   hh)\tSHOULDER PACK, kit number SMSH12;   ii)\tMAJOR SETUP PACK, kit number SMSU17A;   jj)\tTOTAL HIP, kit number SMTH39;   kk)\tTOTAL KNEE, kit number SMTK21;   ll)\tKnee Arthroscopy, kit number SPKA57Q;   mm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P;   nn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF;   oo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF;   pp)\tUPPER EXTREMITY, kit number SRUE05M;   qq)\tArthroscopy Pack, kit number THAR35B;   rr)\tExtremity Pack, kit number THEX27B  ss)\tShoulder Pack, kit number THSH07F  tt)\tTotal Joint, kit number THTJ22G  uu)\tTOTAL HIP PACK, kit number WHTH07D  vv)\tTOTAL HIP PACK, kit number WHTH07E  ww)\tTOTAL KNEE, kit number WHTK06C  xx)\tTOTAL KNEE, kit number WHTK06D  yy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0833-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0833-2024: American Contract Systems, Inc. is recalling Custom procedural convenience kits and trays, Othopedic use, labeled as:    a)\tHIP FRACTURE, kit number AHHF15C;   b)\tHIP FRACTURE, kit number AHHF15D;   c)\tHand Pack, kit number BBHP10E;   d)\tLower Extremity, kit number BBLE40B;   e)\tCustom Podiatry, kit number BOCP70J;   f)\tROBOTIC PACK, kit number BPAR65A;   g)\tHIP PINNING PACK, kit number EMHP84;   h)\tHIP PINNING PK, STRL F G, kit number FHHI17V;   i)\tTOTAL HIP PACK, kit number GNTH06L;   j)\tTOTAL KNEE PACK, kit number GNTK07L;   k)\tEXTREMITY PACK, kit number GUEX48I;   l)\tMAJOR ORTHO PACK, kit number GUMO40J;   m)\tTOTAL KNEE ACCESS PACK, kit number HITK58D;   n)\tSHOULDER ARTHROSCOPY, kit number HNSH17H;   o)\tTOTAL HIP PACK, kit number HNTH76M;   p)\tTOTAL KNEE PACK, kit number HNTK81M;   q)\tORIF HIP PACK, kit number HOHP28;   r)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S;   s)\tCustom Lower Ext, kit number JSLE08E;   t)\tHAND PACK, kit number LVHD29;   u)\tKIT, LOWER EXTREMITY, kit number MMEX19E;   v)\tKIT, HIP PINNING, kit number MMHP45E;   w)\tKIT, ORTHO SPINE, kit number MMSP21H;   x)\tKIT, TOTAL HIP, kit number MMTH15E;   y)\tKIT, TOTAL KNEE, kit number MMTK66E;   z)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E;   aa)\tHIP SCOPE, kit number PTHS10D;   bb)\tHIP SCOPE, kit number PTHS10F;   cc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D;   dd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F;   ee)\tTOTAL ORTHO SAH, kit number SATO27F;   ff)\tTOTAL ORTHO SAH, kit number SATO27G;   gg)\tPODIATRY PACK, kit number SMPD35;   hh)\tSHOULDER PACK, kit number SMSH12;   ii)\tMAJOR SETUP PACK, kit number SMSU17A;   jj)\tTOTAL HIP, kit number SMTH39;   kk)\tTOTAL KNEE, kit number SMTK21;   ll)\tKnee Arthroscopy, kit number SPKA57Q;   mm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P;   nn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF;   oo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF;   pp)\tUPPER EXTREMITY, kit number SRUE05M;   qq)\tArthroscopy Pack, kit number THAR35B;   rr)\tExtremity Pack, kit number THEX27B  ss)\tShoulder Pack, kit number THSH07F  tt)\tTotal Joint, kit number THTJ22G  uu)\tTOTAL HIP PACK, kit number WHTH07D  vv)\tTOTAL HIP PACK, kit number WHTH07E  ww)\tTOTAL KNEE, kit number WHTK06C  xx)\tTOTAL KNEE, kit number WHTK06D  yy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E",
      "text": "The FDA logged enforcement record Z-0833-2024: American Contract Systems, Inc. is voluntarily recalling Custom procedural convenience kits and trays, Othopedic use, labeled as:    a)\tHIP FRACTURE, kit number AHHF15C;   b)\tHIP FRACTURE, kit number AHHF15D;   c)\tHand Pack, kit number BBHP10E;   d)\tLower Extremity, kit number BBLE40B;   e)\tCustom Podiatry, kit number BOCP70J;   f)\tROBOTIC PACK, kit number BPAR65A;   g)\tHIP PINNING PACK, kit number EMHP84;   h)\tHIP PINNING PK, STRL F G, kit number FHHI17V;   i)\tTOTAL HIP PACK, kit number GNTH06L;   j)\tTOTAL KNEE PACK, kit number GNTK07L;   k)\tEXTREMITY PACK, kit number GUEX48I;   l)\tMAJOR ORTHO PACK, kit number GUMO40J;   m)\tTOTAL KNEE ACCESS PACK, kit number HITK58D;   n)\tSHOULDER ARTHROSCOPY, kit number HNSH17H;   o)\tTOTAL HIP PACK, kit number HNTH76M;   p)\tTOTAL KNEE PACK, kit number HNTK81M;   q)\tORIF HIP PACK, kit number HOHP28;   r)\tDR. GREENWALD TOTAL KNEE, kit number HSGK80S;   s)\tCustom Lower Ext, kit number JSLE08E;   t)\tHAND PACK, kit number LVHD29;   u)\tKIT, LOWER EXTREMITY, kit number MMEX19E;   v)\tKIT, HIP PINNING, kit number MMHP45E;   w)\tKIT, ORTHO SPINE, kit number MMSP21H;   x)\tKIT, TOTAL HIP, kit number MMTH15E;   y)\tKIT, TOTAL KNEE, kit number MMTK66E;   z)\tKIT, UPPER EXTREMITY OPEN SHOULDER, kit number MMUE31E;   aa)\tHIP SCOPE, kit number PTHS10D;   bb)\tHIP SCOPE, kit number PTHS10F;   cc)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18D;   dd)\tSHOULDER ARTHROSCOPY SAH, kit number SASA18F;   ee)\tTOTAL ORTHO SAH, kit number SATO27F;   ff)\tTOTAL ORTHO SAH, kit number SATO27G;   gg)\tPODIATRY PACK, kit number SMPD35;   hh)\tSHOULDER PACK, kit number SMSH12;   ii)\tMAJOR SETUP PACK, kit number SMSU17A;   jj)\tTOTAL HIP, kit number SMTH39;   kk)\tTOTAL KNEE, kit number SMTK21;   ll)\tKnee Arthroscopy, kit number SPKA57Q;   mm)\tSHOULDER ARTHROSCOPY, kit number SPSA58P;   nn)\tTotal Hip pack W-O Stryker, kit number SPTH50AF;   oo)\tTotal Knee pack W-O Stryker, kit number SPTK51AF;   pp)\tUPPER EXTREMITY, kit number SRUE05M;   qq)\tArthroscopy Pack, kit number THAR35B;   rr)\tExtremity Pack, kit number THEX27B  ss)\tShoulder Pack, kit number THSH07F  tt)\tTotal Joint, kit number THTJ22G  uu)\tTOTAL HIP PACK, kit number WHTH07D  vv)\tTOTAL HIP PACK, kit number WHTH07E  ww)\tTOTAL KNEE, kit number WHTK06C  xx)\tTOTAL KNEE, kit number WHTK06D  yy)\tCARPAL TUNNEL WEXFORD PACK, kit number WXCT12E — reason: During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-11-29. Affected lots/codes: a) AHHF15C, UDI/DI 00191072137524, Lot numbers:  696221, exp. 9/7/2023; 741221, exp. 9/16/2023; 787221, exp. 8/1/2023; 873221, exp. 5/7/2023;  b) AHHF15D, UDI/DI 00191072183552, Lot numbers:  890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023;  c) BBHP10E, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 748221, exp. 9/9/2023; 811221, exp. 7/8/2023; 867221, exp. 5/13/2023; 969231, exp. 1/31/2024;  d) BBLE40B, UDI/DI none, Lot numbers:  679221, exp. 11/17/2023; 743221, exp. 9/14/2023;  e) BOCP70J, UDI/DI none, Lot numbers:  705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023;  f) BPAR65A, UDI/DI 00191072187444, Lot numbers:  960231, exp. 2/9/2024;  g) EMHP84, UDI/DI 00191072094650, Lot numbers:  934231, exp. 9/30/2023; 983231, exp. 10/26/2023; 678221, exp. 9/30/2023; 769221, exp. 8/19/2023; 805221, exp. 7/14/2023; 856221, exp. 5/24/2023; 891221, exp. 4/19/2023;  h) FHHI17V, UDI/DI none, Lot numbers:  708221, exp. 10/19/2023; 651221, exp. 12/15/2023; 939231, exp. 3/2/2024; 885231, exp. 4/25/2024;  i) GNTH06L, UDI/DI 00191072157416, Lot numbers:  896221, exp. 4/14/2023; 778221, exp. 8/10/2023;  j) GNTK07L, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 974231, exp. 1/26/2024;  k) GUEX48I, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 639221, exp. 12/27/2023; 981231, exp. 1/19/2024; 927231, exp. 3/14/2024;  l) GUMO40J, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 638221, exp. 12/28/2023; 975231, exp. 1/25/2024; 893231, exp. 4/17/2024;  m) HITK58D, UDI/DI none, Lot numbers:  773221, exp. 8/15/2023; 717221, exp. 10/10/2023; 991231, exp. 1/9/2024; 935231, exp. 3/6/2024;  n) HNSH17H, UDI/DI none, Lot numbers:  741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024;  o) HNTH76M, UDI/DI none, Lot numbers:  848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024;  p) HNTK81M, UDI/DI none, Lot numbers:  731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024;  q) HOHP28, UDI/DI 00191072171009, Lot numbers:  724221, exp. 10/3/2023; 687221, exp. 11/9/2023; 990231, exp. 1/10/2024; 942231, exp. 2/27/2024;  r) HSGK80S, UDI/DI none, Lot numbers: 689221, exp. 11/7/2023; 668221, exp. 11/28/2023; 969231, exp. 1/31/2024; 932231, exp. 9/3/2024; 871231, exp. 5/9/2024;   s) JSLE08E, UDI/DI 00191072135773, Lot numbers:  895221, exp. 4/15/2023;  t) LVHD29, UDI/DI 00191072062512, Lot numbers:  737221, exp. 9/20/2023; 716221, exp. 10/11/2023; 681221, exp. 11/15/2023; 650221, exp. 12/16/2023; 989231, exp. 1/11/2024; 942231, exp. 2/27/2024;  u) MMEX19E, UDI/DI none, Lot numbers:  966231, exp. 2/3/2024; 893231, exp. 4/17/2024;  v) MMHP45E, UDI/DI none, Lot numbers:  879231, exp. 5/1/2024;  w) MMSP21H, UDI/DI none, Lot numbers:  927231, exp. 3/14/2024;  x) MMTH15E, UDI/DI none, Lot numbers:  688221, exp. 11/8/2023; 654221, exp. 12/12/2023; 968231, exp. 2/1/2024;  y) MMTK66E, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 991231, exp. 1/9/2024;  z) MMUE31E, UDI/DI none, Lot numbers:  919231, exp. 3/22/2024;  aa) PTHS10D, UDI/DI 00191072131362, Lot numbers:  646221, exp. 12/20/2023; 675221, exp. 9/5/2023; 720221, exp. 10/7/2023; 778221, exp. 8/10/2023;  bb) PTHS10F, UDI/DI 00191072131362, Lot numbers:  918231, exp. 9/5/2023; 984231, exp. 1/16/2024;  cc) SASA18D, UDI/DI none, Lot numbers:  885221, exp. 4/25/2023;  dd) SASA18F, UDI/DI none, Lot numbers:  663221, exp. 12/3/2023; 701221, exp. 10/26/2023; 726221, exp. 10/012023; 800221, exp. 7/19/2023; 981231, exp. 1/19/2024;  ee) SATO27F, UDI/DI none, Lot numbers:  833221, exp. 6/16/2023; 870221, exp. 5/10/2023;  ff) SATO27G, UDI/DI none, Lot numbers:  652221, exp. 12/14/2023; 695221, exp. 11/1/2023; 722221, exp. 10/5/2023; 756221, exp. 9/1/2023; 7912210, exp. 7/28/2023; 925231, exp. 3/16/2024; 954321, exp. 2/15/2024; 989231, exp. 1/11/2024;  gg) SMPD35, UDI/DI  00191072188496, Lot numbers:  961231, exp. 2/8/2024;  hh) SMSH12, UDI/DI  00191072188502, Lot numbers:  970231, exp. 1/30/2024; 899231, exp. 4/11/2024;  ii) SMSU17A, UDI/DI  00191072188519, Lot numbers:  938231, exp. 3/3/2024; 918231, exp. 3/23/2024; jj) SMTH39, UDI/DI  00191072188526, Lot numbers:  961231, exp. 2/8/2024; 928231, exp. 3/13/2024;  kk) SMTK21, UDI/DI  00191072188533, Lot numbers:  968231, exp. 2/1/2024; 928231, exp. 3/13/2024;  ll) SPKA57Q, UDI/DI  00191072163479, Lot numbers:  773221, exp. 8/15/2023; 707221, exp. 10/20/2023;  mm) SPSA58P, UDI/DI  00191072105264, Lot numbers:  775221, exp. 8/13/2023; 706221, exp. 10/21/2023;  nn) SPTH50AF, UDI/DI  00191072163448, Lot numbers:  833221, exp. 6/16/2023; 797221, exp. 7/22/2023;  oo) SPTK51AF, UDI/DI  00191072163486, Lot numbers:  709221, exp. 10/18/2023; 702221, exp. 10/25/2023;  pp) SRUE05M, UDI/DI  00191072185761, Lot numbers:  878231, exp. 5/2/2024;  qq) THAR35B, UDI/DI  00191072153340, Lot numbers:  708221, exp. 10/19/2023; 701221, exp. 10/26/2023;  rr) THEX27B, UDI/DI  00191072166074, Lot numbers:  778221, exp. 8/10/2023; 687221, exp. 11/9/2023;  ss) THSH07F, UDI/DI  00191072163493, Lot numbers:  791221, exp. 7/28/2023; 741221, exp. 9/16/2023;  tt) THTJ22G, UDI/DI  00191072189889, Lot numbers:  716221, exp. 10/11/2023; 708221, exp. 10/19/2023;  uu) WHTH07D, UDI/DI none, Lot numbers:  693221, exp. 11/3/2023; 730221, exp. 9/27/2023; 772221, exp. 8/16/2023; 804221, exp. 7/15/2023; 856221, exp. 5/24/2023;  vv) WHTH07E, UDI/DI none, Lot numbers:  646221, exp. 12/20/2023; 933231, exp. 3/18/2024; 969231, exp. 1/31/2024; 991231, exp. 1/9/2024;  ww) WHTK06C, UDI/DI none, Lot numbers:  709221, exp. 10/18/2023; 766221, exp. 8/22/2023; 806221, exp. 7/13/2023; 861221, exp. 5/19/2023;  xx) WHTK06D, UDI/DI none, Lot numbers:  654221, exp. 12/12/2023; 966231, exp. 2/3/2023;  yy) WXCT12E, UDI/DI  00191072053671, Lot numbers:  959231, exp. 2/10/2024; 696221, exp. 10/31/2023; 703221, exp. 10/24/2023; 731221, exp. 9/26/2023; 786221, exp. 8/2/2023; 862221, exp. 5/18/2023;. 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-0833-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0833-2024&lang=eng"
        }
      },
      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0833-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0833-2024 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-0833-2024&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-0833-2024&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0833-2024/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0833-2024",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0833-2024",
            "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": "American Contract Systems, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "During an internal investigation, ACS identified that several components were \"piggybacked\" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the \"piggybacked\" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the  piggybacked  components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-11-29",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) AHHF15C, UDI/DI 00191072137524, Lot numbers:  696221, exp. 9/7/2023; 741221, exp. 9/16/2023; 787221, exp. 8/1/2023; 873221, exp. 5/7/2023;  b) AHHF15D, UDI/DI 00191072183552, Lot numbers:  890231, exp. 4/21/2024; 959231, exp. 2/10/2024; 652221, exp. 9/5/2023;  c) BBHP10E, UDI/DI none, Lot numbers:  678221, exp. 11/18/2023; 748221, exp. 9/9/2023; 811221, exp. 7/8/2023; 867221, exp. 5/13/2023; 969231, exp. 1/31/2024;  d) BBLE40B, UDI/DI none, Lot numbers:  679221, exp. 11/17/2023; 743221, exp. 9/14/2023;  e) BOCP70J, UDI/DI none, Lot numbers:  705221, exp. 10/22/2023; 747221, exp. 9/10/2023; 839221, exp. 6/10/2023;  f) BPAR65A, UDI/DI 00191072187444, Lot numbers:  960231, exp. 2/9/2024;  g) EMHP84, UDI/DI 00191072094650, Lot numbers:  934231, exp. 9/30/2023; 983231, exp. 10/26/2023; 678221, exp. 9/30/2023; 769221, exp. 8/19/2023; 805221, exp. 7/14/2023; 856221, exp. 5/24/2023; 891221, exp. 4/19/2023;  h) FHHI17V, UDI/DI none, Lot numbers:  708221, exp. 10/19/2023; 651221, exp. 12/15/2023; 939231, exp. 3/2/2024; 885231, exp. 4/25/2024;  i) GNTH06L, UDI/DI 00191072157416, Lot numbers:  896221, exp. 4/14/2023; 778221, exp. 8/10/2023;  j) GNTK07L, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 974231, exp. 1/26/2024;  k) GUEX48I, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 639221, exp. 12/27/2023; 981231, exp. 1/19/2024; 927231, exp. 3/14/2024;  l) GUMO40J, UDI/DI none, Lot numbers:  715221, exp. 10/12/2023; 638221, exp. 12/28/2023; 975231, exp. 1/25/2024; 893231, exp. 4/17/2024;  m) HITK58D, UDI/DI none, Lot numbers:  773221, exp. 8/15/2023; 717221, exp. 10/10/2023; 991231, exp. 1/9/2024; 935231, exp. 3/6/2024;  n) HNSH17H, UDI/DI none, Lot numbers:  741221, exp. 9/16/2023; 989231, exp. 1/11/2024; 949231, exp. 2/20/2024;  o) HNTH76M, UDI/DI none, Lot numbers:  848221, exp. 6/1/2023; 702221, exp. 10/25/2023; 980231, exp. 1/20/2024;  p) HNTK81M, UDI/DI none, Lot numbers:  731221, exp. 9/26/2023; 689221, exp. 11/7/2023; 966231, exp. 2/3/2024;  q) HOHP28, UDI/DI 00191072171009, Lot numbers:  724221, exp. 10/3/2023; 687221, exp. 11/9/2023; 990231, exp. 1/10/2024; 942231, exp. 2/27/2024;  r) HSGK80S, UDI/DI none, Lot numbers: 689221, exp. 11/7/2023; 668221, exp. 11/28/2023; 969231, exp. 1/31/2024; 932231, exp. 9/3/2024; 871231, exp. 5/9/2024;   s) JSLE08E, UDI/DI 00191072135773, Lot numbers:  895221, exp. 4/15/2023;  t) LVHD29, UDI/DI 00191072062512, Lot numbers:  737221, exp. 9/20/2023; 716221, exp. 10/11/2023; 681221, exp. 11/15/2023; 650221, exp. 12/16/2023; 989231, exp. 1/11/2024; 942231, exp. 2/27/2024;  u) MMEX19E, UDI/DI none, Lot numbers:  966231, exp. 2/3/2024; 893231, exp. 4/17/2024;  v) MMHP45E, UDI/DI none, Lot numbers:  879231, exp. 5/1/2024;  w) MMSP21H, UDI/DI none, Lot numbers:  927231, exp. 3/14/2024;  x) MMTH15E, UDI/DI none, Lot numbers:  688221, exp. 11/8/2023; 654221, exp. 12/12/2023; 968231, exp. 2/1/2024;  y) MMTK66E, UDI/DI none, Lot numbers:  680221, exp. 11/16/2023; 991231, exp. 1/9/2024;  z) MMUE31E, UDI/DI none, Lot numbers:  919231, exp. 3/22/2024;  aa) PTHS10D, UDI/DI 00191072131362, Lot numbers:  646221, exp. 12/20/2023; 675221, exp. 9/5/2023; 720221, exp. 10/7/2023; 778221, exp. 8/10/2023;  bb) PTHS10F, UDI/DI 00191072131362, Lot numbers:  918231, exp. 9/5/2023; 984231, exp. 1/16/2024;  cc) SASA18D, UDI/DI none, Lot numbers:  885221, exp. 4/25/2023;  dd) SASA18F, UDI/DI none, Lot numbers:  663221, exp. 12/3/2023; 701221, exp. 10/26/2023; 726221, exp. 10/012023; 800221, exp. 7/19/2023; 981231, exp. 1/19/2024;  ee) SATO27F, UDI/DI none, Lot numbers:  833221, exp. 6/16/2023; 870221, exp. 5/10/2023;  ff) SATO27G, UDI/DI none, Lot numbers:  652221, exp. 12/14/2023; 695221, exp. 11/1/2023; 722221, exp. 10/5/2023; 756221, exp. 9/1/2023; 7912210, exp. 7/28/2023; 925231, exp. 3/16/2024; 954321, exp. 2/15/2024; 989231, exp. 1/11/2024;  gg) SMPD35, UDI/DI  00191072188496, Lot numbers:  961231, exp. 2/8/2024;  hh) SMSH12, UDI/DI  00191072188502, Lot numbers:  970231, exp. 1/30/2024; 899231, exp. 4/11/2024;  ii) SMSU17A, UDI/DI  00191072188519, Lot numbers:  938231, exp. 3/3/2024; 918231, exp. 3/23/2024; jj) SMTH39, UDI/DI  00191072188526, Lot numbers:  961231, exp. 2/8/2024; 928231, exp. 3/13/2024;  kk) SMTK21, UDI/DI  00191072188533, Lot numbers:  968231, exp. 2/1/2024; 928231, exp. 3/13/2024;  ll) SPKA57Q, UDI/DI  00191072163479, Lot numbers:  773221, exp. 8/15/2023; 707221, exp. 10/20/2023;  mm) SPSA58P, UDI/DI  00191072105264, Lot numbers:  775221, exp. 8/13/2023; 706221, exp. 10/21/2023;  nn) SPTH50AF, UDI/DI  00191072163448, Lot numbers:  833221, exp. 6/16/2023; 797221, exp. 7/22/2023;  oo) SPTK51AF, UDI/DI  00191072163486, Lot numbers:  709221, exp. 10/18/2023; 702221, exp. 10/25/2023;  pp) SRUE05M, UDI/DI  00191072185761, Lot numbers:  878231, exp. 5/2/2024;  qq) THAR35B, UDI/DI  00191072153340, Lot numbers:  708221, exp. 10/19/2023; 701221, exp. 10/26/2023;  rr) THEX27B, UDI/DI  00191072166074, Lot numbers:  778221, exp. 8/10/2023; 687221, exp. 11/9/2023;  ss) THSH07F, UDI/DI  00191072163493, Lot numbers:  791221, exp. 7/28/2023; 741221, exp. 9/16/2023;  tt) THTJ22G, UDI/DI  00191072189889, Lot numbers:  716221, exp. 10/11/2023; 708221, exp. 10/19/2023;  uu) WHTH07D, UDI/DI none, Lot numbers:  693221, exp. 11/3/2023; 730221, exp. 9/27/2023; 772221, exp. 8/16/2023; 804221, exp. 7/15/2023; 856221, exp. 5/24/2023;  vv) WHTH07E, UDI/DI none, Lot numbers:  646221, exp. 12/20/2023; 933231, exp. 3/18/2024; 969231, exp. 1/31/2024; 991231, exp. 1/9/2024;  ww) WHTK06C, UDI/DI none, Lot numbers:  709221, exp. 10/18/2023; 766221, exp. 8/22/2023; 806221, exp. 7/13/2023; 861221, exp. 5/19/2023;  xx) WHTK06D, UDI/DI none, Lot numbers:  654221, exp. 12/12/2023; 966231, exp. 2/3/2023;  yy) WXCT12E, UDI/DI  00191072053671, Lot numbers:  959231, exp. 2/10/2024; 696221, exp. 10/31/2023; 703221, exp. 10/24/2023; 731221, exp. 9/26/2023; 786221, exp. 8/2/2023; 862221, exp. 5/18/2023;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}