McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
type: Dataset
description: FDA recall Z-2636-2024 — Covidien is recalling McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only (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.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
  type: MedicalDevice
  manufacturer: Covidien
claims: FDA recall Z-2636-2024: Covidien is recalling McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
claims: FDA classified recall Z-2636-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2636-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2636-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class I
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Covidien
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-09
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI: 15060272980020 05060272980023 F0602729800201/ All serial Numbers prior to 366170 and Lot/serial number: 370723 370727 370729 370733 370756 370757 370759 370760 370762 370763 370764 370766 370767 370768 370769 370770 370772 370773 370774 370775 370776 370777 370778 370779 370842 370898 370900 370901 370902 370904 370905 370907 370908 370911 370913 370917 370938 370939 370940 370941 370966 370967 370984 370985 370988 370992 371000 371002 371012 371016 371018 371037 371064 371065 371066 371067 371068 371069 371070 371071 371072 371074 371076 371109 371113 371114 371115 371116 371117 371118 371119 371121 371122 371123 371124 371125 371126 371127 371128 371130 371131 371132 371135 371136 371138 371139 371140 371141 371142 371144 371145 371146 371172 371173 371175 371176 371177 371180 371181 371182 371183 371184 371185 371186 371188 371189 371190 371192 371193 371194 371195 371230 371232 371234 371235 371236 371242 371244 371245 371247 371248 371249 371252 371253 371254 371255 371259 371262 371265 371266 371267 371269 371270 371273 371276 371277 371278 371279 371281 371282 371283 371285 371289 371290 371291 371293 371295 371297 371298 371302 371303 371307 371308 371309 371358 371438 371573 371575 371577 371578 371579 371580 371581 371582 371583 371584 371588 371589 371590 371591 371592 371593 371594 371595 371596 371597 371598 371599 371629 371630 371633 371635 371659 371660 371661 371662 371663 371664 371666 371667 371668 371669 371670 371671 371672 371673 371674 371675 371677 371678 371679 371680 371681 371682 371683 371709 371710 371711 371712 371713 371714 371715 371716 371717 371719 371720 371721 371722 371723 371724 371725 371726 371727 371728 371730 371731 371732 371733 371738 371739 371743 371744 371745 371746 371747 371748 371749 371750 371751 371752 371753 371759 371760 371761 371762 371763 371764 371765 371766 371767 371768 371769 371770 371771 371772 371773 371774 371775 371776 371777 371778 371779 371780 371781 371782 371783 371806 371807 371809 371810 3…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - US 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia, Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Rep. Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania Luxembourg Macao Malaysia Maldives Malta Martinique Mauritius Mexico Moldova, Republic of Mongolia, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russian Federation, Rwanda, Saint Martin, Saint Pierre And Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Viet Nam, Virgin Islands, U.S. Wallis And Futuna.
      status: recorded

FDA recall Z-2636-2024: Covidien is recalling McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
type: Claim
text: The FDA logged enforcement record Z-2636-2024: Covidien is voluntarily recalling McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only — reason: Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-09. Affected lots/codes: UDI: 15060272980020 05060272980023 F0602729800201/ All serial Numbers prior to 366170 and Lot/serial number: 370723 370727 370729 370733 370756 370757 370759 370760 370762 370763 370764 370766 370767 370768 370769 370770 370772 370773 370774 370775 370776 370777 370778 370779 370842 370898 370900 370901 370902 370904 370905 370907 370908 370911 370913 370917 370938 370939 370940 370941 370966 370967 370984 370985 370988 370992 371000 371002 371012 371016 371018 371037 371064 371065 371066 371067 371068 371069 371070 371071 371072 371074 371076 371109 371113 371114 371115 371116 371117 371118 371119 371121 371122 371123 371124 371125 371126 371127 371128 371130 371131 371132 371135 371136 371138 371139 371140 371141 371142 371144 371145 371146 371172 371173 371175 371176 371177 371180 371181 371182 371183 371184 371185 371186 371188 371189 371190 371192 371193 371194 371195 371230 371232 371234 371235 371236 371242 371244 371245 371247 371248 371249 371252 371253 371254 371255 371259 371262 371265 371266 371267 371269 371270 371273 371276 371277 371278 371279 371281 371282 371283 371285 371289 371290 371291 371293 371295 371297 371298 371302 371303 371307 371308 371309 371358 371438 371573 371575 371577 371578 371579 371580 371581 371582 371583 371584 371588 371589 371590 371591 371592 371593 371594 371595 371596 371597 371598 371599 371629 371630 371633 371635 371659 371660 371661 371662 371663 371664 371666 371667 371668 371669 371670 371671 371672 371673 371674 371675 371677 371678 371679 371680 371681 371682 371683 371709 371710 371711 371712 371713…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
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.

FDA classified recall Z-2636-2024 as Class I
type: Claim
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.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class I
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
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.

What an FDA recall is — and is NOT
type: Claim
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.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
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.