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  "name": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures.",
  "description": "FDA recall Z-2562-2024 — Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures. (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": "Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures.",
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      "name": "Merit Medical Systems, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2562-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2562-2024: Merit Medical Systems, Inc. is recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures.",
      "text": "The FDA logged enforcement record Z-2562-2024: Merit Medical Systems, Inc. is voluntarily recalling Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    K04 (Custom Syringe Kit), REF:  K05-00203M  K05-00511J  K05-00547J  K05-00612Q  K05-00819A  K05-01030H  K05-01274D  K05-01646  K05-01688A  K05-01717B  K05-01880K  K05-01890D  K05-01945A  K05-01954A  K05-02247A  K05-02436B  K05-02507  K05-02511A  K05-02954  K05-02982A    To support various vascular or cardiac diagnostic and interventional procedures. — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-11. Affected lots/codes: Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484  Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275  Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495  Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467  Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243  Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246  Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930  Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483  Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319  Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892 H2849102 H2854783 H2864807 H2869821 H2911094 H2920493  Catalog Number: K05-01880K UDI-DI code: 00884450250082 Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509  Catalog Number: K05-01890D UDI-DI code: 00884450448465 Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425  Catalog Number: K05-01945A UDI-DI code: 00884450190425 Lot Numbers: H2629623  Catalog Number: K05-01954A UDI-DI code: 00884450200643 Lot Numbers: H2629622  Catalog Number: K05-02247A UDI-DI code: 00884450141915 Lot Numbers: H2632850  Catalog Number: K05-02436B UDI-DI code: 00884450450253 Lot Numbers: H2393542 H2429834 H2450827 H2490409 H2495792 H2526835 H2542711 H2564295 H2581946 H2643007 H2674545 H2681527 H2687258 H2899223  Catalog Number: K05-02507 UDI-DI code: 00884450136850 Lot Numbers: H2348365 H2353310 H2369280 H2385672 H2390242 H2398231 H2412975 H2416155 H2427243 H2436679 H2443286 H2446096 H2450076 H2466702 H2511700 H2516470 H2522736 H2533989 H2553744 H2560064 H2564513 H2584038 H2618874 H2629469 H2639227 H2645485 H2659923 H2675984 H2693156 H2721337 H2733185 H2746808 H2751331 H2779140 H2819920 H2871550 H2880714 H2925260  Catalog Number: K05-02511A UDI-DI code: 00884450543115 Lot Numbers: H2739521 H2765683 H2901045  Catalog Number: K05-02954 UDI-DI code: 00884450298350 Lot Numbers: H2725969  Catalog Number: K05-02982A UDI-DI code: 00884450639511 Lot Numbers: H2382003 H2420219. A RECORDED FDA enforcement action (occurred=true).",
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        "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-2562-2024&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-2562-2024&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-2562-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2562-2024 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,
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      "grounding": {
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        "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-2562-2024&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-2562-2024&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-2562-2024/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,
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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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            "Value": "Z-2562-2024",
            "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,
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            "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": "Merit Medical Systems, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-06-11",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number: K05-00203M UDI-DI code: 00884450138229 Lot Numbers: H2629466 H2645484  Catalog Number: K05-00511J UDI-DI code: 00884450271773 Lot Numbers: H2397984 H2412868 H2426797 H2446029 H2450196 H2482980 H2492350 H2511643 H2539331 H2549658 H2583385 H2594873 H2629250 H2654820 H2673730 H2697598 H2739498 H2756187 H2770202 H2801817 H2819960 H2834477 H2845285 H2890830 H2912779 H2925275  Catalog Number: K05-00547J UDI-DI code: 00884450312049 Lot Numbers: H2645495  Catalog Number: K05-00612Q UDI-DI code: 00884450138519 Lot Numbers: H2629467  Catalog Number: K05-00819A UDI-DI code: 00884450273470 Lot Numbers: H2639243  Catalog Number: K05-01030H UDI-DI code: 00884450394502 Lot Numbers: H2362663 H2385684 H2398244 H2443304 H2454819 H2503278 H2534002 H2584049 H2613765 H2639245 H2669271 H2713730 H2726182 H2739451 H2830115 H2845244 H2912708 H2925246  Catalog Number: K05-01274D UDI-DI code: 00884450160596 Lot Numbers: H2628681 H2659930  Catalog Number: K05-01646 UDI-DI code: 00884450139240 Lot Numbers: H2468170 H2610232 H2669236 H2761568 H2834483  Catalog Number: K05-01688A UDI-DI code: 00884450450260 Lot Numbers: H2383009 H2397922 H2412414 H2430164 H2451023 H2454910 H2542861 H2576902 H2619765 H2718026 H2821398 H2823953 H2844957 H2846857 H2895319  Catalog Number: K05-01717B UDI-DI code: 00884450139325 Lot Numbers: H2404146S1 H2410692 H2476492 H2495715 H2516725 H2520817 H2548562 H2557492 H2564607 H2576953 H2589882 H2613573 H2640670 H2650871 H2697189 H2736533 H2767978 H2787955 H2823896 H2844892 H2849102 H2854783 H2864807 H2869821 H2911094 H2920493  Catalog Number: K05-01880K UDI-DI code: 00884450250082 Lot Numbers: H2415380 H2415389 H2520099 H2521297 H2558149 H2581890 H2602338 H2626908 H2725829 H2758376 H2787928 H2796059 H2810014 H2828097 H2859867 H2864769 H2874962 H2885296 H2899952 H2915446 H2927509  Catalog Number: K05-01890D UDI-DI code: 00884450448465 Lot Numbers: H2420188 H2470760 H2557921 H2581894 H2602345 H2641626 H2871425  Catalog Number: K05-01945A UDI-DI code: 00884450190425 Lot Numbers: H2629623  Catalog Number: K05-01954A UDI-DI code: 00884450200643 Lot Numbers: H2629622  Catalog Number: K05-02247A UDI-DI code: 00884450141915 Lot Numbers: H2632850  Catalog Number: K05-02436B UDI-DI code: 00884450450253 Lot Numbers: H2393542 H2429834 H2450827 H2490409 H2495792 H2526835 H2542711 H2564295 H2581946 H2643007 H2674545 H2681527 H2687258 H2899223  Catalog Number: K05-02507 UDI-DI code: 00884450136850 Lot Numbers: H2348365 H2353310 H2369280 H2385672 H2390242 H2398231 H2412975 H2416155 H2427243 H2436679 H2443286 H2446096 H2450076 H2466702 H2511700 H2516470 H2522736 H2533989 H2553744 H2560064 H2564513 H2584038 H2618874 H2629469 H2639227 H2645485 H2659923 H2675984 H2693156 H2721337 H2733185 H2746808 H2751331 H2779140 H2819920 H2871550 H2880714 H2925260  Catalog Number: K05-02511A UDI-DI code: 00884450543115 Lot Numbers: H2739521 H2765683 H2901045  Catalog Number: K05-02954 UDI-DI code: 00884450298350 Lot Numbers: H2725969  Catalog Number: K05-02982A UDI-DI code: 00884450639511 Lot Numbers: H2382003 H2420219",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.",
            "Status": "recorded"
          }
        }
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}