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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1971-2025.jsonld",
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  "name": "BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060",
  "description": "FDA recall Z-1971-2025 — BD SWITZERLAND SARL is recalling BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060 (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",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "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-1971-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060",
    "manufacturer": {
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      "name": "BD SWITZERLAND SARL"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1971-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1971-2025: BD SWITZERLAND SARL is recalling BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060",
      "text": "The FDA logged enforcement record Z-1971-2025: BD SWITZERLAND SARL is voluntarily recalling BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060 — reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-12. Affected lots/codes: UDI-DI/Lot(Expiration): MY8003/10885403221651/23125144(December 5, 2026), 24015468(January 20, 2027), 24025611(February 5, 2027), 24026390(February 27, 2027), 24036107(March 25, 2027), 24045647(April 24, 2027), 24055859(May 27, 2027), 24095513(September 24, 2027), 92217803(June 27, 2025), 92225801(September 15, 2025), 92231303(November 9, 2025), 92300201(January 2, 2026), 92308702(March 28, 2026), 92309501(April 5, 2026), 92313601(May 16, 2026), 92315701(June 6, 2026)  MY8005/10885403221668/23125145(December 5, 2026), 24015467(January 20, 2027), 24026387(February 27, 2027), 24045646(April 24, 2027), 24055858(May 27, 2027), 24075164(July 26, 2027), 24095512(September 24, 2027), 92215201(June 1, 2025), 92220802(July 27, 2025), 92225502(September 12, 2025), 92315102(May 31, 2026);  MY8010/10885403221675/24015312(January 15, 2027), 24025610(February 5, 2027), 24045645(April 24, 2027), 24055857(May 27, 2027), 24066953(June 25, 2027), 24075165(July 26, 2027), 24085486(August 26, 2027), 24095511(September 24, 2027), 24105167(October 25, 2027), 92218601(July 5, 2025), 92222902(August 17, 2025), 92223601(August 24, 2025), 92229201(October 19, 2025), 92230701(November 3, 2025), 92231301(November 9, 2025), 92231302(November 9, 2025), 92307402(March 15, 2026), 92311601(April 26, 2026), 92315101(May 31, 2026);  MY8020/10885403221682/23115069(November 3, 2026), 24015311(January 15, 2027), 24025935(February 7, 2027), 24035566(March 5, 2027), 24036106(March 25, 2027), 24045644(April 24, 2027), 24055856(May 27, 2027), 24066952(June 25, 2027), 24075163(July 26, 2027), 24085485(August 26, 2027), 24095083(September 9, 2027), 24105196(October 30, 2027), 92216401(June 13, 2025), 92217801(June 27, 2025), 92218001(June 29, 2025), 92219202(July 11, 2025), 92231901(November 15, 2025), 92300205(January 2, 2026), 92300902(January 9, 2026), 92309503(April 5, 2026), 92310101(April 11, 2026), 92313002(May 10, 2026), 92313602(May 16, 2026)  MY8030/10885403230523/23115070(November 3, 2026), 23125143(December 5, 2026), 24015264(January 12, 2027), 24015644(January 27, 2027), 24026389(February 27, 2027), 24036105(March 25, 2027), 24045643(April 24, 2027), 24055855(May 27, 2027), 24075162(July 26, 2027), 24085484(August 26, 2027), 24095509(September 24, 2027), 24115110(November 5, 2027), 92225501(September 12, 2025), 92233602(December 2, 2025), 92307403(March 15, 2026), 92308701(March 28, 2026), 92309502(April 5, 2026), 92315702(June 6, 2026), 92316402(June 13, 2026), 24066951(June 25, 2027);  MY8060/10885403221699/23115496(November 28, 2026), 23125393(December 18, 2026), 24015102(January 8, 2027), 24026388(February 27, 2027), 24036104(March 25, 2027), 24045366(April 23, 2027), 24055854(May 27, 2027), 24075166(July 26, 2027), 24095596(September 24, 2027), 24115111(November 14, 2027), 92216402(June 13, 2025), 92222002(August 8, 2025), 92222901(August 17, 2025), 92224303(August 31, 2025), 92224301(August 31, 2025), 92226502(September 22, 2025), 92228501(October 12, 2025), 92230702(November 3, 2025), 92230703(November 3, 2025), 92230704(November 3, 2025), 92300202(January 2, 2026), 92300203(January 2, 2026), 92306703(March 8, 2026), 92306701(March 8, 2026), 92306702(March 8, 2026), 92311602(April 26, 2026), 92312302(May 3, 2026), 92313001(May 10, 2026), 92316601(June 15, 2026), 92316602(June 15, 2026). 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-1971-2025&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-1971-2025&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-1971-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1971-2025 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-1971-2025&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-1971-2025&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-1971-2025/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-1971-2025",
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1971-2025",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "BD SWITZERLAND SARL",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.",
            "Status": "recorded"
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        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-05-12",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI/Lot(Expiration): MY8003/10885403221651/23125144(December 5, 2026), 24015468(January 20, 2027), 24025611(February 5, 2027), 24026390(February 27, 2027), 24036107(March 25, 2027), 24045647(April 24, 2027), 24055859(May 27, 2027), 24095513(September 24, 2027), 92217803(June 27, 2025), 92225801(September 15, 2025), 92231303(November 9, 2025), 92300201(January 2, 2026), 92308702(March 28, 2026), 92309501(April 5, 2026), 92313601(May 16, 2026), 92315701(June 6, 2026)  MY8005/10885403221668/23125145(December 5, 2026), 24015467(January 20, 2027), 24026387(February 27, 2027), 24045646(April 24, 2027), 24055858(May 27, 2027), 24075164(July 26, 2027), 24095512(September 24, 2027), 92215201(June 1, 2025), 92220802(July 27, 2025), 92225502(September 12, 2025), 92315102(May 31, 2026);  MY8010/10885403221675/24015312(January 15, 2027), 24025610(February 5, 2027), 24045645(April 24, 2027), 24055857(May 27, 2027), 24066953(June 25, 2027), 24075165(July 26, 2027), 24085486(August 26, 2027), 24095511(September 24, 2027), 24105167(October 25, 2027), 92218601(July 5, 2025), 92222902(August 17, 2025), 92223601(August 24, 2025), 92229201(October 19, 2025), 92230701(November 3, 2025), 92231301(November 9, 2025), 92231302(November 9, 2025), 92307402(March 15, 2026), 92311601(April 26, 2026), 92315101(May 31, 2026);  MY8020/10885403221682/23115069(November 3, 2026), 24015311(January 15, 2027), 24025935(February 7, 2027), 24035566(March 5, 2027), 24036106(March 25, 2027), 24045644(April 24, 2027), 24055856(May 27, 2027), 24066952(June 25, 2027), 24075163(July 26, 2027), 24085485(August 26, 2027), 24095083(September 9, 2027), 24105196(October 30, 2027), 92216401(June 13, 2025), 92217801(June 27, 2025), 92218001(June 29, 2025), 92219202(July 11, 2025), 92231901(November 15, 2025), 92300205(January 2, 2026), 92300902(January 9, 2026), 92309503(April 5, 2026), 92310101(April 11, 2026), 92313002(May 10, 2026), 92313602(May 16, 2026)  MY8030/10885403230523/23115070(November 3, 2026), 23125143(December 5, 2026), 24015264(January 12, 2027), 24015644(January 27, 2027), 24026389(February 27, 2027), 24036105(March 25, 2027), 24045643(April 24, 2027), 24055855(May 27, 2027), 24075162(July 26, 2027), 24085484(August 26, 2027), 24095509(September 24, 2027), 24115110(November 5, 2027), 92225501(September 12, 2025), 92233602(December 2, 2025), 92307403(March 15, 2026), 92308701(March 28, 2026), 92309502(April 5, 2026), 92315702(June 6, 2026), 92316402(June 13, 2026), 24066951(June 25, 2027);  MY8060/10885403221699/23115496(November 28, 2026), 23125393(December 18, 2026), 24015102(January 8, 2027), 24026388(February 27, 2027), 24036104(March 25, 2027), 24045366(April 23, 2027), 24055854(May 27, 2027), 24075166(July 26, 2027), 24095596(September 24, 2027), 24115111(November 14, 2027), 92216402(June 13, 2025), 92222002(August 8, 2025), 92222901(August 17, 2025), 92224303(August 31, 2025), 92224301(August 31, 2025), 92226502(September 22, 2025), 92228501(October 12, 2025), 92230702(November 3, 2025), 92230703(November 3, 2025), 92230704(November 3, 2025), 92300202(January 2, 2026), 92300203(January 2, 2026), 92306703(March 8, 2026), 92306701(March 8, 2026), 92306702(March 8, 2026), 92311602(April 26, 2026), 92312302(May 3, 2026), 92313001(May 10, 2026), 92316601(June 15, 2026), 92316602(June 15, 2026)",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}