FDA recall Z-2636-2024

Covidien · Class I · device

Product

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.

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, Ke

Key facts

Status
Ongoing
Initiation date
2024-07-09
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2636-2024