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  "name": "STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20  STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15    Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.",
  "description": "FDA recall Z-0142-2025 — Physio-Control, Inc. is recalling STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20  STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15    Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. (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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    "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-0142-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20  STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15    Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Physio-Control, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0142-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0142-2025: Physio-Control, Inc. is recalling STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20  STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15    Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.",
      "text": "The FDA logged enforcement record Z-0142-2025: Physio-Control, Inc. is voluntarily recalling STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20  STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15    Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. — reason: Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-08-09. Affected lots/codes: LP20 Model/Catalog Number: 11131-000040 UDI-DI codes:  00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863  Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559  Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560  Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092  LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577  Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891  Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605  Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059. 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-0142-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-0142-2025/fda-classification",
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      "name": "FDA classified recall Z-0142-2025 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.",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0142-2025/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",
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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-0142-2025",
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            "Value": "Z-0142-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "Physio-Control, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-08-09",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "LP20 Model/Catalog Number: 11131-000040 UDI-DI codes:  00883873863558 Part Number: 3317813-001 Serial Numbers: 101648901 86557878 87141562 88458193 88482392 93989670 Part Number: 3317813-005 Serial Number: 107741863  Model/Catalog Number: 11131-000041 UDI-DI code: 00883873863534 Part Number: 3317813-002 Serial Numbers: 86287034 86949592 90445090 91624045 93441890 Part Number: 3317813-006 Serial Number: 107556559  Model/Catalog Number: 11131-000042 UDI-DI code: 00883873863527 Part Number: 3317813-003 Serial Numbers: 100198569 100759224 101002312 101042672 101383090 84830138 84881382 84915416 86240215 86260453 86557878 86949593 87794908 90445091 91380577 92185462 96496375 96496376 96496377 97059498 Part Number: 3317813-007 Serial Numbers: 105817428 106332158 107556560  Model/Catalog Number: 11131-000043 UDI-DI code: 00883873863510 Part Number: 3317813-004 Serial Numbers: 101506304 86949594 90445092  LP15 Model/Catalog Number: 11131-000044 UDI-DI code: 00883873863503 Part Number: 3317814-001 Serial Numbers: 90445093 93441892 98719352 98719353 99649024 99649025 Part Number: 3317814-005 Serial Number: 107124577  Model/Catalog Number: 11131-000045 UDI-DI code: 00883873863497 Part Number: 3317814-003 Serial Numbers: 101888461 101888462 101888463 102107169 103669336 103669337 104125087 104129892 104440600 86280420 90445095 92556517 92871913 95836040 97111384 98719364 98719365 98813631 99692098 Part Number: 3317814-007 Serial Numbers: 106555464 106721716 106917875 106968460 107445069 107741891  Model/Catalog Number: 11131-000046 UDI-DI code: 00883873863480 Part Number: 3317814-004 Serial Numbers: 90445096 98719376 98813643 98990261 99692108 Part Number: 3317814-008 Serial Numbers: 107124605  Model/Catalog Number: 11131-000047 UDI-DI code: 00883873863213 Part Number: 3317814-002 Serial Numbers: 84830141 90445094 91515844 92556516 92871911 93441893 98719358 98719359 99692092 Part Number: 3317814-006 Serial Numbers: 107078533 107445059",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.",
            "Status": "recorded"
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        }
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