PlainRecalls
FDA Devices Critical Class I Ongoing

McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

Reported: August 28, 2024 Initiated: July 9, 2024 #Z-2636-2024

Product Description

McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only

Reason for Recall

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

Details

Recalling Firm
Covidien
Units Affected
75,544 units
Distribution
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.
Location
Boulder, CO

Frequently Asked Questions

What product was recalled?
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only. Recalled by Covidien. Units affected: 75,544 units.
Why was this product recalled?
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Critical. Recall number: Z-2636-2024.