{ "@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" }, "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-0184-2026.jsonld", "@type": "schema:Dataset", "name": "Medical convenience kits Item Number/Description ANSH14AF\tSHOULDER PACK - 205962 EVAH76H\tANTERIOR HIP PACK FDSA15M\tSHOULDER ARTHROSCOPY GRTS90G\tTOTAL SHPULDER PACK HGHI26G\tHIP PINNING PACK HJTO25C\tTOTAL HIP ACCESSORY PACK HNEX60L\tEXTREMITY PACK IAHD53C\tHAND PACK IASH65A\tSHOULDER PACK IHUE40AI\tUPPER EXTREMITY PK| STRL F G ILTJ47AA\tTOTAL JOINT PACK LMHP14Z\tORIF HIP, ST LUKES METHODIS LMSN44AE\tSPINAL PACK MHHP25H\tHAND PACK - 206002 MHTH90AJ\tTOTAL HIP PACK - 206016 MWAH32P\tANTERIOR HIP PACK MWTK13AH\tTOTAL KNEE PLOR89H\tORTHO MINOR PACK RCUE81B\tUPPER EXTREMITY RCH 0247031 TSTH54D\tTOTAL HIP TRAY UDEX85Y\tDSC EXTREMITY - 206050 UDHD69U\tHAND PACK - 206055 UDKN68AH\tCUSTOM KNEE - 206061 UIHN18AW\tACS HAND PACK (PS 020640) UIHN18AX\tACS HAND PACK (PS 020640) UIKN28AR\tASC KNEE PACK (PS 020641) UISO44I\tSFCH SMALL ORTHO PACK (PS 143213)", "description": "FDA recall Z-0184-2026 — American Contract Systems Inc. is recalling Medical convenience kits Item Number/Description ANSH14AF\tSHOULDER PACK - 205962 EVAH76H\tANTERIOR HIP PACK FDSA15M\tSHOULDER ARTHROSCOPY GRTS90G\tTOTAL SHPULDER PACK HGHI26G\tHIP PINNING PACK HJTO25C\tTOTAL HIP ACCESSORY PACK HNEX60L\tEXTREMITY PACK IAHD53C\tHAND PACK IASH65A\tSHOULDER PACK IHUE40AI\tUPPER EXTREMITY PK| STRL F G ILTJ47AA\tTOTAL JOINT PACK LMHP14Z\tORIF HIP, ST LUKES METHODIS LMSN44AE\tSPINAL PACK MHHP25H\tHAND PACK - 206002 MHTH90AJ\tTOTAL HIP PACK - 206016 MWAH32P\tANTERIOR HIP PACK MWTK13AH\tTOTAL KNEE PLOR89H\tORTHO MINOR PACK RCUE81B\tUPPER EXTREMITY RCH 0247031 TSTH54D\tTOTAL HIP TRAY UDEX85Y\tDSC EXTREMITY - 206050 UDHD69U\tHAND PACK - 206055 UDKN68AH\tCUSTOM KNEE - 206061 UIHN18AW\tACS HAND PACK (PS 020640) UIHN18AX\tACS HAND PACK (PS 020640) UIKN28AR\tASC KNEE PACK (PS 020641) UISO44I\tSFCH SMALL ORTHO PACK (PS 143213) (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-0184-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medical convenience kits Item Number/Description ANSH14AF\tSHOULDER PACK - 205962 EVAH76H\tANTERIOR HIP PACK FDSA15M\tSHOULDER ARTHROSCOPY GRTS90G\tTOTAL SHPULDER PACK HGHI26G\tHIP PINNING PACK HJTO25C\tTOTAL HIP ACCESSORY PACK HNEX60L\tEXTREMITY PACK IAHD53C\tHAND PACK IASH65A\tSHOULDER PACK IHUE40AI\tUPPER EXTREMITY PK| STRL F G ILTJ47AA\tTOTAL JOINT PACK LMHP14Z\tORIF HIP, ST LUKES METHODIS LMSN44AE\tSPINAL PACK MHHP25H\tHAND PACK - 206002 MHTH90AJ\tTOTAL HIP PACK - 206016 MWAH32P\tANTERIOR HIP PACK MWTK13AH\tTOTAL KNEE PLOR89H\tORTHO MINOR PACK RCUE81B\tUPPER EXTREMITY RCH 0247031 TSTH54D\tTOTAL HIP TRAY UDEX85Y\tDSC EXTREMITY - 206050 UDHD69U\tHAND PACK - 206055 UDKN68AH\tCUSTOM KNEE - 206061 UIHN18AW\tACS HAND PACK (PS 020640) UIHN18AX\tACS HAND PACK (PS 020640) UIKN28AR\tASC KNEE PACK (PS 020641) UISO44I\tSFCH SMALL ORTHO PACK (PS 143213)", "manufacturer": { "@type": "schema:Organization", "name": "American Contract Systems Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0184-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-0184-2026: American Contract Systems Inc. is recalling Medical convenience kits Item Number/Description ANSH14AF\tSHOULDER PACK - 205962 EVAH76H\tANTERIOR HIP PACK FDSA15M\tSHOULDER ARTHROSCOPY GRTS90G\tTOTAL SHPULDER PACK HGHI26G\tHIP PINNING PACK HJTO25C\tTOTAL HIP ACCESSORY PACK HNEX60L\tEXTREMITY PACK IAHD53C\tHAND PACK IASH65A\tSHOULDER PACK IHUE40AI\tUPPER EXTREMITY PK| STRL F G ILTJ47AA\tTOTAL JOINT PACK LMHP14Z\tORIF HIP, ST LUKES METHODIS LMSN44AE\tSPINAL PACK MHHP25H\tHAND PACK - 206002 MHTH90AJ\tTOTAL HIP PACK - 206016 MWAH32P\tANTERIOR HIP PACK MWTK13AH\tTOTAL KNEE PLOR89H\tORTHO MINOR PACK RCUE81B\tUPPER EXTREMITY RCH 0247031 TSTH54D\tTOTAL HIP TRAY UDEX85Y\tDSC EXTREMITY - 206050 UDHD69U\tHAND PACK - 206055 UDKN68AH\tCUSTOM KNEE - 206061 UIHN18AW\tACS HAND PACK (PS 020640) UIHN18AX\tACS HAND PACK (PS 020640) UIKN28AR\tASC KNEE PACK (PS 020641) UISO44I\tSFCH SMALL ORTHO PACK (PS 143213)", "text": "The FDA logged enforcement record Z-0184-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits Item Number/Description ANSH14AF\tSHOULDER PACK - 205962 EVAH76H\tANTERIOR HIP PACK FDSA15M\tSHOULDER ARTHROSCOPY GRTS90G\tTOTAL SHPULDER PACK HGHI26G\tHIP PINNING PACK HJTO25C\tTOTAL HIP ACCESSORY PACK HNEX60L\tEXTREMITY PACK IAHD53C\tHAND PACK IASH65A\tSHOULDER PACK IHUE40AI\tUPPER EXTREMITY PK| STRL F G ILTJ47AA\tTOTAL JOINT PACK LMHP14Z\tORIF HIP, ST LUKES METHODIS LMSN44AE\tSPINAL PACK MHHP25H\tHAND PACK - 206002 MHTH90AJ\tTOTAL HIP PACK - 206016 MWAH32P\tANTERIOR HIP PACK MWTK13AH\tTOTAL KNEE PLOR89H\tORTHO MINOR PACK RCUE81B\tUPPER EXTREMITY RCH 0247031 TSTH54D\tTOTAL HIP TRAY UDEX85Y\tDSC EXTREMITY - 206050 UDHD69U\tHAND PACK - 206055 UDKN68AH\tCUSTOM KNEE - 206061 UIHN18AW\tACS HAND PACK (PS 020640) UIHN18AX\tACS HAND PACK (PS 020640) UIKN28AR\tASC KNEE PACK (PS 020641) UISO44I\tSFCH SMALL ORTHO PACK (PS 143213) — 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: AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A; ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192; EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760; FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299; GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A; HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A; HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159; HNEX60L 191072193643 lot 8487711 bag serial number 68641794; IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092; IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A; IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A; ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822; LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A; LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A; MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A; MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A; MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A; MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A; PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107; RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959; TSTH54D UDI-DI 191072229878 lot 8411811 bag serial number 68666214; UDEX85Y UDI-DI 191072216267 lot 8047611 bag serial number N/A; UDHD69U UDI-DI 191072216298 lot 7991811 bag serial number 17402072; UDKN68AH UDI-DI 191072226013 lot 8046511 bag serial number 68045970; UIHN18AW UDI-DI 191072228956 lot 8025311 bag serial number 68153870; UIHN18AX UDI-DI 191072234049 lot 8192211 bag serial number 68195746; UIKN28AR UDI-DI 191072228970 lot 8049011 bag serial number 68135550; UISO44I UDI-DI 191072205407 lot 8027311 bag serial number 68153822 * If bag serial number is listed as \"N/A\", then whole lot is affected. 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-0184-2026&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-0184-2026&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-0184-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-0184-2026 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-0184-2026&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-0184-2026&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-0184-2026/boundary", "@type": "schema:Claim", "name": "What an FDA recall is — and is NOT", "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-0184-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-0184-2026", "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": "American Contract Systems Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "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" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-09-04", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "AMEX26AA UDI-DI 191072207340 lot 7958811 bag serial number N/A; ANSH14AF UDI-DI 00191072214461 lot 8137411 bag serial numbers 68274173 68274192; EVAH76H UDI-DI 191072221858 lot 8367611 bag serial number 68566760; FDSA15M UDI-DI 191072185396 lot 8076011 bag serial number 68117299; GRTS90G UDI-DI 191072208262 lot 8532411 bag serial number N/A; HGHI26G UDI-DI 191072212559 lot 8161611 bag serial number N/A; HJTO25C UDI-DI 191072105684 lot 8071011 bag serial numbers 17505916 17506159; HNEX60L 191072193643 lot 8487711 bag serial number 68641794; IAHD53C UDI-DI 191072232564 lot 8128911 bag serial number 47395092; IASH65A UDI-DI 191072224477 lot 8058211 bag serial number N/A; IHUE40AI UDI-DI 191072234100 lot 8181611 bag serial number N/A; ILTJ47AA UDI-DI 197012208279 lot 8518611 bag serial number 68865822; LMHP14Z UDI-DI 191072202932 lot 8136111 bag serial number N/A; LMSN44AE UDI-DI 191072236265 lot 8450311 bag serial number N/A; MHHP25H UDI-DI 191072214983 lot 7986811 bag serial number N/A; MHTH90AJ UDI-DI 191072216120 lot 7982511 bag serial number N/A; MWAH32P UDI-DI 191072208538 lot 7974911 bag serial number N/A; MWTK13AH UDI-DI 191072225344 lot 8040111 bag serial number N/A; PLOR89H UDI-DI 191072225740 lot 8172511 bag serial numbers 47394380 47498107; RCUE81B UDI-DI 191072226266 lot 8065011 bag serial number 68137959; TSTH54D UDI-DI 191072229878 lot 8411811 bag serial number 68666214; UDEX85Y UDI-DI 191072216267 lot 8047611 bag serial number N/A; UDHD69U UDI-DI 191072216298 lot 7991811 bag serial number 17402072; UDKN68AH UDI-DI 191072226013 lot 8046511 bag serial number 68045970; UIHN18AW UDI-DI 191072228956 lot 8025311 bag serial number 68153870; UIHN18AX UDI-DI 191072234049 lot 8192211 bag serial number 68195746; UIKN28AR UDI-DI 191072228970 lot 8049011 bag serial number 68135550; UISO44I UDI-DI 191072205407 lot 8027311 bag serial number 68153822 * If bag serial number is listed as \"N/A\", then whole lot is affected", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.", "Status": "recorded" } } ] } ] }