CLASS II ONGOING Device recall · Reported 11 Mar 2020 · FDA Enforcement Report

McGRATH X3 Disposable Laryngoscope Blades-used recalled by Medtronic

Medtronic is recalling McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to, distributed nationwide in the US. The recall was initiated on 28 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121

Quantity recalled109,897

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1408-2020
FDA event ID: 84819
Recalling firm: Medtronic, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 28 Jan 2020
FDA classified: 28 Feb 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Jan 2020	Recall initiated by company
28 Feb 2020	Classified by FDA	+31 days
11 Mar 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

Product as listed by the FDA

McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

Where it was distributed

Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,Greece, Guadeloupe, Ireland, Hungry, Italy, Jordan, Kazakhstan, Lithuania, Lebanon, Luxembourg, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, Saudia Arabia, Sweden, Serbia, Slovakia, Turkey, Tunisia, United Arab Emirates, United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

Which lots are affected?

UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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