Hearth Record

McGRATH” MAC EMS Video Laryngoscope

Medical device recall Z-2637-2024. Published in FDA’s Enforcement Report on Aug 28, 2024.

  • FDA Class I
FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Aug 28, 2024. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class I, the most serious of FDA’s three classes.

“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”

openFDA, in plain words, its enforcement report fields.

“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

FDA’s rule, 21 CFR 7.3(m)(1), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

McGRATH” MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only

10,449 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

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…

Every code shown here, 1,997 characters

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…

FDA’s list runs to 32,369 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

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.

The states and territories these words name

53 states and territories.

Every one of them
  • Alaska
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • North Dakota
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Puerto Rico
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • US Virgin Islands
  • Vermont
  • Washington
  • Wisconsin
  • West Virginia
  • Wyoming

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Jul 9, 2024.
  • FDA classified it on Aug 21, 2024.
  • FDA’s Enforcement Report published it on Aug 28, 2024.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Covidien, of Boulder, CO.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 32,369 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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