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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1688-2024.jsonld",
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  "name": "Brand Name: PIEZON Bottle  Product Name: PIEZON Bottle  Model/Catalog Number: EG-111  Software Version: N/A  Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE",
  "description": "FDA recall Z-1688-2024 — Electro Medical Systems SA is recalling Brand Name: PIEZON Bottle  Product Name: PIEZON Bottle  Model/Catalog Number: EG-111  Software Version: N/A  Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE (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: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-1688-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: PIEZON Bottle  Product Name: PIEZON Bottle  Model/Catalog Number: EG-111  Software Version: N/A  Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Electro Medical Systems SA"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1688-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1688-2024: Electro Medical Systems SA is recalling Brand Name: PIEZON Bottle  Product Name: PIEZON Bottle  Model/Catalog Number: EG-111  Software Version: N/A  Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE",
      "text": "The FDA logged enforcement record Z-1688-2024: Electro Medical Systems SA is voluntarily recalling Brand Name: PIEZON Bottle  Product Name: PIEZON Bottle  Model/Catalog Number: EG-111  Software Version: N/A  Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use.  Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE — reason: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-13. Affected lots/codes: Lot Code: Model number: EG-111, UDI: 07613353180249 Lot number: 16442-190, Expiry date: 2026-04 Model number: EG-111, UDI: 07613353180249 Lot number: 16694-30 Expiry date: 2026-07   AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124  Product Serial Numbers: KU23667 KU23689 KU23700 KU23701 KU23703 KU23722 KU24328 KU24330 KU24331 KU24333 KU24334 KU24335 KU24337 KU24339 KU24340 KU24341 KU23719 KU24336 KU24338 KU24342 KU24344 KU24346 KU24349 KU24354 KU24356 KU23666 KU23672 KU23678 KU23686 KU23688 KU23706 KU23716 KU24343 KU24345 KU24347 KU24348 KU24350 KU24351 KU24353 KU24355 KU24357 KU24363 KU24366 KU24367 KU24368 KU24369 KU24370 KU24371 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365. 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-1688-2024&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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1688-2024/fda-classification",
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      "name": "FDA classified recall Z-1688-2024 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.",
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          "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-1688-2024&lang=eng"
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      },
      "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."
    },
    {
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      "@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",
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        "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-1688-2024",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1688-2024",
            "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Electro Medical Systems SA",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-03-13",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: Model number: EG-111, UDI: 07613353180249 Lot number: 16442-190, Expiry date: 2026-04 Model number: EG-111, UDI: 07613353180249 Lot number: 16694-30 Expiry date: 2026-07   AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124  Product Serial Numbers: KU23667 KU23689 KU23700 KU23701 KU23703 KU23722 KU24328 KU24330 KU24331 KU24333 KU24334 KU24335 KU24337 KU24339 KU24340 KU24341 KU23719 KU24336 KU24338 KU24342 KU24344 KU24346 KU24349 KU24354 KU24356 KU23666 KU23672 KU23678 KU23686 KU23688 KU23706 KU23716 KU24343 KU24345 KU24347 KU24348 KU24350 KU24351 KU24353 KU24355 KU24357 KU24363 KU24366 KU24367 KU24368 KU24369 KU24370 KU24371 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of  ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA  REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.",
            "Status": "recorded"
          }
        }
      ]
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}