# FDA recall Z-1408-2020

> **Medtronic, PLC** · Class II · device recall initiated 2020-01-28.

## Product

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.

## 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

## Distribution

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.

## Key facts

- **Recall number:** Z-1408-2020
- **Recalling firm:** Medtronic, PLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-01-28
- **Report date:** 2020-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2020

## Citation

> AI Analytics. FDA recall Z-1408-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1408-2020. Source: US FDA. Licensed CC0.

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