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  "name": "MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:      a)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;   b)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15;   c)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22;   d)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30;   e)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18;   f)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22;   g)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30;   h)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22;   i)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16;   j)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18;   k)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22",
  "description": "FDA recall Z-1186-2024 — Avanos Medical, Inc. is recalling MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:      a)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;   b)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15;   c)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22;   d)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30;   e)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18;   f)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22;   g)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30;   h)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22;   i)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16;   j)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18;   k)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22 (Devices, Class I). 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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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1186-2024&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:      a)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;   b)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15;   c)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22;   d)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30;   e)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18;   f)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22;   g)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30;   h)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22;   i)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16;   j)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18;   k)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22",
    "manufacturer": {
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      "name": "Avanos Medical, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1186-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1186-2024: Avanos Medical, Inc. is recalling MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:      a)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;   b)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15;   c)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22;   d)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30;   e)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18;   f)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22;   g)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30;   h)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22;   i)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16;   j)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18;   k)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22",
      "text": "The FDA logged enforcement record Z-1186-2024: Avanos Medical, Inc. is voluntarily recalling MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors:      a)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16;   b)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-15;   c)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-22;   d)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16-30;   e)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18;   f)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-22;   g)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 18 Fr, Product Code 8250-18-30;   h)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Endoscopic/Radiologic Placement - 22 Fr, Product Code 8250-22;   i)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 16 Fr, Product Code 8260-16;   j)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 18 Fr, Product Code 8260-18;   k)\tMIC* Gastric-Jejunal Feeding Tube Kit with ENFit¿ Connector - Surgical Placement - 22 Fr, Product Code 8260-22 — reason: MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-16. Affected lots/codes: a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers:  30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862;   b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers:  30226822, 30242228, 30253956;   c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers:  30184814, 30226821, 30247088, 30253955, 30262508, 30226820;   d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers:  30231400, 30238125 30247087, 30250300, 30258135, 30265373;   e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers:  30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505;   f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers:  30184824, 30228970, 30240302, 30247094, 30257066;   g) Product Code 8250-18-30, UDI/DI 00350770445472,  Batch Numbers:  30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861;   h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers:  30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860;   i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers:  30181845, 30223861,  30256484, 30290828;   j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers:  30185408, 30233438, 30242225, 30259226, 30264282, 30290830;   k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers:  30256483, 30259564, 30290829. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1186-2024&lang=eng",
        "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-1186-2024&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-1186-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1186-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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-1186-2024&lang=eng",
        "value": "Class I",
        "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-1186-2024&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-1186-2024/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,
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      "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-1186-2024",
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            "Value": "Z-1186-2024",
            "Status": "recorded"
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            "Status": "recorded"
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            "Value": "Class I",
            "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": "Avanos Medical, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-16",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) Product Code 8250-16, UDI/DI 350770445410, Batch Numbers:  30180762, 30226671, 30226823, 30233440, 30238985, 30242039, 30254749, 30265005, 30266483, 30265374, 30268260, 30270862;   b) Product Code 8250-16-15, UDI/DI 350770445427, Batch Numbers:  30226822, 30242228, 30253956;   c) Product Code 8250-16-22, UDI/DI 00350770445434, Batch Numbers:  30184814, 30226821, 30247088, 30253955, 30262508, 30226820;   d) Product Code 8250-16-30, UDI/DI 00350770445441, Batch Numbers:  30231400, 30238125 30247087, 30250300, 30258135, 30265373;   e) Product Code 8250-18, UDI/DI 00350770445458, Batch Numbers:  30181846, 30184760, 30185381, 30226672, 30229833, 30233376, 30233439, 30235094, 30238124, 30238984, 30250140, 30251089, 30250169, 30254748, 30255675, 30256486, 80402128, 30259225, 30259566, 30261699, 30262040, 30264284, 30267593, 30268259, 30270505;   f) Product Code 8250-18-22, UDI/DI 00350770445465, Batch Numbers:  30184824, 30228970, 30240302, 30247094, 30257066;   g) Product Code 8250-18-30, UDI/DI 00350770445472,  Batch Numbers:  30181900, 30226819, 30228969, 30240301, 30247092, 30252989, 30253953, 30259565, 30265004, 30265372, 30270861;   h) Product Code 8250-22, UDI/DI 00350770445489, Batch Numbers:  30184759, 30185380, 30186750, 30221235, 30226670, 30226818, 30228968, 30238123, 30238475, 30238983, 30242226, 30242037, 30252072, 30252985, 30252998, 30255676, 30254747, 30256485, 30259224, 30262039, 30264283, 30267123, 30268258, 30270504, 30270860;   i) Product Code 8260-16, UDI/DI 00350770445496, Batch Numbers:  30181845, 30223861,  30256484, 30290828;   j) Product Code 8260-18, UDI/DI 00350770445502, Batch Numbers:  30185408, 30233438, 30242225, 30259226, 30264282, 30290830;   k) Product Code 8260-22 UDI/DI 00350770445519, Batch Numbers:  30256483, 30259564, 30290829",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution: US (nationwide) to 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, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including PR; and OUS (foreign) countries of: Canada, Colombia, Costa Rica, UAB, Israel, Kuwait, and Panama.",
            "Status": "recorded"
          }
        }
      ]
    }
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}