Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
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📍Recalling firmCovidien6135 Gunbarrel Ave · Boulder, CO 80301-3214
✎ GovInfoNow plain-language explainer
Covidien is a well-known company that produces a wide range of medical devices such as surgical instruments, endoscopes, and other healthcare products. They are a major player in the medical device industry. Read more at govinfonow.com/recall/54676-covidien-medical-devices.
“Covidien - Medical Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54676-covidien-medical-devices. Based on FDA recall #Z-2636-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2636-2024%22&limit=1).
The FDA has issued a Class I recall for Covidien's LMA Supreme™ (Laryngeal Mask Airway) due to the risk of improper fit, which may lead to inadequate ventilation and potential patient harm.
How to tell if you have it
Covidien
LMA Supreme™
The hazard
Improper fit may result in inadequate ventilation, hypoxia, or other respiratory complications during anesthesia or airway management procedures.
Context
This recall is part of a broader pattern of safety concerns involving Covidien's airway and respiratory care products. Recent recalls include issues with bedside SpO2 monitors (alarms not heard), Newport HT70 ventilators (risk of shutdown), and Shiley tracheostomy tubes (cuff flange disconnect). These incidents highlight ongoing quality control challenges in the company's critical care device portfolio.
How to tell if you have this one
Ensure that the products are used according to the manufacturer's instructions and that they are regularly maintained and inspected.
Brand
Covidien
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
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.
If a device malfunctions, stop using it immediately and contact the manufacturer or a healthcare professional for assistance.
How to ensure product safety
Regularly check the product for any signs of damage or wear and ensure it is used as per the manufacturer's guidelines.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2636-2024 (July 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2636-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.