Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
type: Dataset
description: FDA recall Z-2717-2024 — Covidien is recalling Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly (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.
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: Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
  type: MedicalDevice
  manufacturer: Covidien
claims: FDA recall Z-2717-2024: Covidien is recalling Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
claims: FDA classified recall Z-2717-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2717-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2717-2024
      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 II
      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: IFU update to address device's battery handling information.
      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: Lot Code: 10884521823396 and 10884521776494: Serial Number/Lot Code: 000082 000100 000101 000106 000109 000113 000114 000118 000134 000137 000142 000145 000147 000158 000169 000177 000204 000206 000214 000215 000220 000236 000240 000242 000245 000246 000257 000266 000268 000272 000280 000290 000294 000295 000298 000301 000302 000304 000311 000313 000323 000328 000330 000331 000333 000334 000338 000341 000343 000344 000347 000348 000351 000352 000362 000363 000365 000370 000373 000374 000380 000383 000390 000400 000409 000412 000417 000418 000422 000426 000429 000430 000433 000443 000444 000450 000459 000463 000471 000473 000484 000489 000492 000494 000508 000511 000515 000532 000534 000540 000545 000548 000551 000554 000555 000570 000573 000579 000588 000589 000591 000594 000600 000603 000608 000612 000615 000626 000627 000632 000634 000637 000638 000647 000652 000653 000659 000661 000667 000670 000671 000674 000675 000676 000685 000686 000690 000692 000696 000701 000703 000710 000711 000724 000731 000732 000734 000736 000737 000742 000743 000746 000747 000748 000754 000759 000762 000763 000770 000771 000773 000774 000780 000783 000786 000790 000791 000792 000794 000798 000802 000805 000815 000818 000819 000820 000824 000825 000828 000829 000830 000832 000833 000834 000835 000836 000837 000838 000840 000841 000842 000843 000845 000846 000848 000849 000851 000852 000853 000854 000855 000856 000857 000858 000859 000860 000861 000862 000863 000864 000865 000866 000867 000868 000869 000870 000872 000873 000874 000875 000876 000877 000878 000880 000881 000882 000883 000884 000885 000886 000888 000889 000890 000892 000893 000894 000895 000896 000897 000898 000899 000900 000901 000902 000903 000905 000906 000907 000908 000909 000910 000911 000912 000915 000916 000917 000919 000920 000921 000922 000923 000924 000925 000926 000927 000929 000930 000931 000932 000933 000934 000935 000936 000937 000938 000940 000941 000942 000943 000944 000945 000946 000947 000948 000949 000951…
      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, US Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia And 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, Puerto Rico, 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-2717-2024: Covidien is recalling Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
type: Claim
text: The FDA logged enforcement record Z-2717-2024: Covidien is voluntarily recalling Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly — reason: IFU update to address device's battery handling information.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-09. Affected lots/codes: Lot Code: 10884521823396 and 10884521776494: Serial Number/Lot Code: 000082 000100 000101 000106 000109 000113 000114 000118 000134 000137 000142 000145 000147 000158 000169 000177 000204 000206 000214 000215 000220 000236 000240 000242 000245 000246 000257 000266 000268 000272 000280 000290 000294 000295 000298 000301 000302 000304 000311 000313 000323 000328 000330 000331 000333 000334 000338 000341 000343 000344 000347 000348 000351 000352 000362 000363 000365 000370 000373 000374 000380 000383 000390 000400 000409 000412 000417 000418 000422 000426 000429 000430 000433 000443 000444 000450 000459 000463 000471 000473 000484 000489 000492 000494 000508 000511 000515 000532 000534 000540 000545 000548 000551 000554 000555 000570 000573 000579 000588 000589 000591 000594 000600 000603 000608 000612 000615 000626 000627 000632 000634 000637 000638 000647 000652 000653 000659 000661 000667 000670 000671 000674 000675 000676 000685 000686 000690 000692 000696 000701 000703 000710 000711 000724 000731 000732 000734 000736 000737 000742 000743 000746 000747 000748 000754 000759 000762 000763 000770 000771 000773 000774 000780 000783 000786 000790 000791 000792 000794 000798 000802 000805 000815 000818 000819 000820 000824 000825 000828 000829 000830 000832 000833 000834 000835 000836 000837 000838 000840 000841 000842 000843 000845 000846 000848 000849 000851 000852 000853 000854 000855 000856 000857 000858 000859 000860 000861 000862 000863 000864 000865 000866 000867 000868 000869 000870 000872 000873 000874 000875 000876 000877 000878 000880 000881 000882 000883 000884 000885 000886 000888 000889 000890 000892 000893 000894 000895 000896 0…
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-2717-2024 as Class II
type: Claim
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.
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 II
  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.