McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
type: Dataset
description: FDA recall Z-2637-2024 — Covidien is recalling McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , 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 EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
  type: MedicalDevice
  manufacturer: Covidien
claims: FDA recall Z-2637-2024: Covidien is recalling McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
claims: FDA classified recall Z-2637-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2637-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2637-2024
      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: 15060272980112. All serial Numbers prior to 366170 and Lot/Serial Numbers:373090 366392 366474 372653 372729 372974 373035 373044 373063 373086 373504 373507 377641 377646 377653 377667 377669 377924 378165 378301 378318 378417 378420 378471 382906 383017 383303 383304 383386 383394 383414 383440 383441 383484 383505 383506 383507 383541 383675 383763 383765 390634 390640 390662 390671 390682 390696 390753 390766 395275 395358 395364 395373 395411 395419 395527 395577 395591 395658 395665 395668 395671 395691 395704 395749 395827 395849 395871 395894 395895 395909 395926 396011 396031 396073 396247 396263 401797 401798 401842 401855 401860 401956 401964 402000 402017 402046 402140 402235 402241 402269 402272 373100 373101 373102 373103 373104 373105 373106 373107 373108 373111 373112 373113 373114 373115 373116 373117 373118 373119 373120 373121 373122 373123 373124 373125 373126 373127 373128 373131 373132 373133 373134 373135 373136 373137 373138 373139 373140 373141 373142 373143 373144 373145 373147 373148 373149 373150 373151 373152 373153 373154 373155 373156 373157 373158 373159 373160 373161 373162 373164 373165 373167 373168 373169 373170 373171 373172 373173 373174 373175 373176 373177 373178 373179 373180 373181 373182 373183 373186 373187 373188 373189 373190 373191 373193 373194 373195 373196 373197 373198 373199 373200 373201 373202 373203 373204 373205 373206 373207 373208 373209 373210 373211 373212 373213 373214 373215 373216 373217 373219 373220 373221 373222 373223 373225 373226 373227 373228 373230 373231 373232 373233 373234 373235 373236 373237 373238 373239 373240 373242 373243 373244 373245 373246 373247 373249 373250 373251 373252 373253 373254 373255 373256 373257 373258 373259 373260 373261 373262 373263 373264 373265 373266 373267 373268 373269 373270 373271 373272 373273 373274 373275 373276 373277 373278 373279 373280 373281 373284 373285 373286 373287 373288 373289 373290 373291 373292 373293 366170 366176 366180 366187 366189 366…
      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-2637-2024: Covidien is recalling McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
type: Claim
text: The FDA logged enforcement record Z-2637-2024: Covidien is voluntarily recalling McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , 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: 15060272980112. All serial Numbers prior to 366170 and Lot/Serial Numbers:373090 366392 366474 372653 372729 372974 373035 373044 373063 373086 373504 373507 377641 377646 377653 377667 377669 377924 378165 378301 378318 378417 378420 378471 382906 383017 383303 383304 383386 383394 383414 383440 383441 383484 383505 383506 383507 383541 383675 383763 383765 390634 390640 390662 390671 390682 390696 390753 390766 395275 395358 395364 395373 395411 395419 395527 395577 395591 395658 395665 395668 395671 395691 395704 395749 395827 395849 395871 395894 395895 395909 395926 396011 396031 396073 396247 396263 401797 401798 401842 401855 401860 401956 401964 402000 402017 402046 402140 402235 402241 402269 402272 373100 373101 373102 373103 373104 373105 373106 373107 373108 373111 373112 373113 373114 373115 373116 373117 373118 373119 373120 373121 373122 373123 373124 373125 373126 373127 373128 373131 373132 373133 373134 373135 373136 373137 373138 373139 373140 373141 373142 373143 373144 373145 373147 373148 373149 373150 373151 373152 373153 373154 373155 373156 373157 373158 373159 373160 373161 373162 373164 373165 373167 373168 373169 373170 373171 373172 373173 373174 373175 373176 373177 373178 373179 373180 373181 373182 373183 373186 373187 373188 373189 373190 373191 373193 373194 373195 373196 373197 373198 373199 373200 373201 373202 373203 373204 373205 373206 373207 373208 373209 373210 373211 373212 373213 373214 373215 373216 373217 373219 373220 373221 373222 373223 373225 373226 373227 373228 373230 373231 373232 373233 373…
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-2637-2024 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.