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  "name": "Medical convenience kits     Item number/ Product description  AKGN82E\tGENERAL  AMCB08Y\tCHEST BREAST PACK  ANBP10AC\tBASIC PACK - 205939  ANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G\tLAPAROTOMY PACK  CIBL33I\tBASIC LAP PACK  EVMN24E\tMINOR ESC  EVST48E\tSTARTER  FDTA11AA\tT & A PACK  FHHY25P\tHYSTEROSCOPY PACK  HGML99G\tMAJOR LAP PACK  HGXR41H\tX-RAY PACK  HISU54M\tSET-UP PACK  IHAA19AP\tPK A A A  IHMP89K\tMINOR PROCEDURE PACK  IHPD14AM\tPK PEDIATRIC  LKVG10O\tVAG DELIVERY  LMAG20G\tVASCULAR PACK  LMLE46AA\tEXTREMITY LOWER PK  MIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H\tMAJOR BASIN SET 314666  OWBS11U\tBASIN SET - 206021  RCMS71B\tMIS SPECIALTY RCH  SFMB55X\tMINOR BASIN - 208293  STBA09F\tBASIN SET   TNBS21O\tBASIN SET 612833  UDBH37AX\tBASIC HEART PACK - 206044  UDMA50X\tMINOR ADULT - 206067  UICR54W\tACS CRS PACK (PS055042)  UIPC89D\tPROCUREMENT PACK  UIPT13F\tPITCHER (PS 907953)  UISB96AB\tSMALL BACK TABLE SETUP (PS 907419)",
  "description": "FDA recall Z-0172-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item number/ Product description  AKGN82E\tGENERAL  AMCB08Y\tCHEST BREAST PACK  ANBP10AC\tBASIC PACK - 205939  ANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G\tLAPAROTOMY PACK  CIBL33I\tBASIC LAP PACK  EVMN24E\tMINOR ESC  EVST48E\tSTARTER  FDTA11AA\tT & A PACK  FHHY25P\tHYSTEROSCOPY PACK  HGML99G\tMAJOR LAP PACK  HGXR41H\tX-RAY PACK  HISU54M\tSET-UP PACK  IHAA19AP\tPK A A A  IHMP89K\tMINOR PROCEDURE PACK  IHPD14AM\tPK PEDIATRIC  LKVG10O\tVAG DELIVERY  LMAG20G\tVASCULAR PACK  LMLE46AA\tEXTREMITY LOWER PK  MIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H\tMAJOR BASIN SET 314666  OWBS11U\tBASIN SET - 206021  RCMS71B\tMIS SPECIALTY RCH  SFMB55X\tMINOR BASIN - 208293  STBA09F\tBASIN SET   TNBS21O\tBASIN SET 612833  UDBH37AX\tBASIC HEART PACK - 206044  UDMA50X\tMINOR ADULT - 206067  UICR54W\tACS CRS PACK (PS055042)  UIPC89D\tPROCUREMENT PACK  UIPT13F\tPITCHER (PS 907953)  UISB96AB\tSMALL BACK TABLE SETUP (PS 907419) (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item number/ Product description  AKGN82E\tGENERAL  AMCB08Y\tCHEST BREAST PACK  ANBP10AC\tBASIC PACK - 205939  ANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G\tLAPAROTOMY PACK  CIBL33I\tBASIC LAP PACK  EVMN24E\tMINOR ESC  EVST48E\tSTARTER  FDTA11AA\tT & A PACK  FHHY25P\tHYSTEROSCOPY PACK  HGML99G\tMAJOR LAP PACK  HGXR41H\tX-RAY PACK  HISU54M\tSET-UP PACK  IHAA19AP\tPK A A A  IHMP89K\tMINOR PROCEDURE PACK  IHPD14AM\tPK PEDIATRIC  LKVG10O\tVAG DELIVERY  LMAG20G\tVASCULAR PACK  LMLE46AA\tEXTREMITY LOWER PK  MIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H\tMAJOR BASIN SET 314666  OWBS11U\tBASIN SET - 206021  RCMS71B\tMIS SPECIALTY RCH  SFMB55X\tMINOR BASIN - 208293  STBA09F\tBASIN SET   TNBS21O\tBASIN SET 612833  UDBH37AX\tBASIC HEART PACK - 206044  UDMA50X\tMINOR ADULT - 206067  UICR54W\tACS CRS PACK (PS055042)  UIPC89D\tPROCUREMENT PACK  UIPT13F\tPITCHER (PS 907953)  UISB96AB\tSMALL BACK TABLE SETUP (PS 907419)",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0172-2026/enforcement-record",
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      "name": "FDA recall Z-0172-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item number/ Product description  AKGN82E\tGENERAL  AMCB08Y\tCHEST BREAST PACK  ANBP10AC\tBASIC PACK - 205939  ANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G\tLAPAROTOMY PACK  CIBL33I\tBASIC LAP PACK  EVMN24E\tMINOR ESC  EVST48E\tSTARTER  FDTA11AA\tT & A PACK  FHHY25P\tHYSTEROSCOPY PACK  HGML99G\tMAJOR LAP PACK  HGXR41H\tX-RAY PACK  HISU54M\tSET-UP PACK  IHAA19AP\tPK A A A  IHMP89K\tMINOR PROCEDURE PACK  IHPD14AM\tPK PEDIATRIC  LKVG10O\tVAG DELIVERY  LMAG20G\tVASCULAR PACK  LMLE46AA\tEXTREMITY LOWER PK  MIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H\tMAJOR BASIN SET 314666  OWBS11U\tBASIN SET - 206021  RCMS71B\tMIS SPECIALTY RCH  SFMB55X\tMINOR BASIN - 208293  STBA09F\tBASIN SET   TNBS21O\tBASIN SET 612833  UDBH37AX\tBASIC HEART PACK - 206044  UDMA50X\tMINOR ADULT - 206067  UICR54W\tACS CRS PACK (PS055042)  UIPC89D\tPROCUREMENT PACK  UIPT13F\tPITCHER (PS 907953)  UISB96AB\tSMALL BACK TABLE SETUP (PS 907419)",
      "text": "The FDA logged enforcement record Z-0172-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item number/ Product description  AKGN82E\tGENERAL  AMCB08Y\tCHEST BREAST PACK  ANBP10AC\tBASIC PACK - 205939  ANIR77AM\tINTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G\tLAPAROTOMY PACK  CIBL33I\tBASIC LAP PACK  EVMN24E\tMINOR ESC  EVST48E\tSTARTER  FDTA11AA\tT & A PACK  FHHY25P\tHYSTEROSCOPY PACK  HGML99G\tMAJOR LAP PACK  HGXR41H\tX-RAY PACK  HISU54M\tSET-UP PACK  IHAA19AP\tPK A A A  IHMP89K\tMINOR PROCEDURE PACK  IHPD14AM\tPK PEDIATRIC  LKVG10O\tVAG DELIVERY  LMAG20G\tVASCULAR PACK  LMLE46AA\tEXTREMITY LOWER PK  MIEN58A\tDTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H\tMAJOR BASIN SET 314666  OWBS11U\tBASIN SET - 206021  RCMS71B\tMIS SPECIALTY RCH  SFMB55X\tMINOR BASIN - 208293  STBA09F\tBASIN SET   TNBS21O\tBASIN SET 612833  UDBH37AX\tBASIC HEART PACK - 206044  UDMA50X\tMINOR ADULT - 206067  UICR54W\tACS CRS PACK (PS055042)  UIPC89D\tPROCUREMENT PACK  UIPT13F\tPITCHER (PS 907953)  UISB96AB\tSMALL BACK TABLE SETUP (PS 907419) — reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-04. Affected lots/codes: AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448;  AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042;  ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117;  ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621;  CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706;  CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A;  EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257;  EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868;  FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258;  FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897;  HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067;  HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A;  HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513;  IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038;  IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486;  IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149;  LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A;  LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A;  LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780;  MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A;  NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A;  OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial numbers 47507802 47508002 47508012;  RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A;  SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A;  SFMB55Y UDI-DI 191072229991 Lot 8096711 Bag serial number N/A Lot 8179711 Bag serial numbers  17556181 17557278;  STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128;  TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A;  UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number 68703044;  UDMA50X UDI-DI 191072172587 Lot 8084711 Bag serial number 17390548 Lot 8183611 Bag serial number 17554620;  UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A;  UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A;  UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422;  UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A  * If \"N/A\" for bag serial number, then whole lot is affected. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "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-0172-2026&lang=eng"
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      "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-0172-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0172-2026 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
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      "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-0172-2026&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-0172-2026&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-0172-2026/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",
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        "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-0172-2026",
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            "Value": "Z-0172-2026",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-04",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "AKGN82E UDI-DI 191072229281 Lot 7352211 Bag serial number 47384448;  AMCB08Y UDI-DI 191072185082 Lot 8069911 Bag serial number 68117042;  ANBP10AC UDI-DI 191072214300 Lot 8125811 Bag serial numbers 17487164 17488117;  ANIR77AM UDI-DI 191072236692 Lot 8394711 Bag serial numbers 58588193 58588194 68563615 68663621;  CFLA39G UDI-DI 191072203496 Lot 8484911 Bag serial numbers 68642706;  CIBL33I UDI-DI 191072186409 Lot 8044011 Bag serial number N/A;  EVMN24E UDI-DI 191072215093 Lot 8184711 Bag serial number 68198257;  EVST48E UDI-DI 191072224064 Lot 7366711 Bag serial number 68194868;  FDTA11AA UDI-DI 191072159236 Lot 8522811 Bag serial number 47864258;  FHHY25P UDI-DI 191072157256 Lot 8031711 Bag serial number 68152897;  HGML99G UDI-DI 191072212580 Lot 8316911 Bag serial number 68244067;  HGXR41H UDI-DI 191072212672 Lot 8285311 Bag serial number N/A;  HISU54M UDI-DI 191072212399 Lot 7969611 Bag serial number 17427513;  IHAA19AP UDI-DI 191072224187 Lot 8035011 Bag serial number 68048038;  IHMP89K UDI-DI 191072159960 Lot 8024811 Bag serial number 68154486;  IHPD14AM UDI-DI 191072227232 Lot 8180911 Bag serial number 68200149;  LKVG10O UDI-DI 191072158666 Lot 7957411 Bag serial number N/A;  LMAG20G UDI-DI 191072158680 Lot 7964411 Bag serial number N/A;  LMLE46AA UDI-DI 191072237880 Lot 8500811 Bag serial number 68642780;  MIEN58A UDI-DI 191072231444 Lot 8118411 Bag serial number N/A;  NUMB04H UDI-DI 191072202895 Lot 7993111 Bag serial number N/A;  OWBS11U UDI-DI 191072214843 Lot 8069411 Bag serial numbers 47507802 47508002 47508012;  RCMS71B UDI-DI 191072226150 Lot 7950311 Bag serial number N/A;  SFMB55X UDI-DI 191072217851 Lot 7971211 Bag serial number N/A;  SFMB55Y UDI-DI 191072229991 Lot 8096711 Bag serial number N/A Lot 8179711 Bag serial numbers  17556181 17557278;  STBA09F UDI-DI 191072208798 Lot 8079711 Bag serial number 17506128;  TNBS21O UDI-DI 191072199775 Lot 8115211 Bag serial number N/A Lot 8432911 Bag serial number N/A;  UDBH37AX UDI-DI 191072238740 Lot 8454211 Bag serial number 68703044;  UDMA50X UDI-DI 191072172587 Lot 8084711 Bag serial number 17390548 Lot 8183611 Bag serial number 17554620;  UICR54W UDI-DI 191072228932 Lot 8142811 Bag serial number N/A;  UIPC89D UDI-DI 191072205742 Lot 7956111 Bag serial number N/A;  UIPT13F UDI-DI 191072107121 Lot 8049111 Bag serial number 68047422;  UISB96AB UDI-DI 191072205797 Lot 8147011 Bag serial number N/A  * If \"N/A\" for bag serial number, then whole lot is affected",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
            "Status": "recorded"
          }
        }
      ]
    }
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}