FDA Device recall Z-1408-2020
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-00…
- FDA Device
- Class II
- ongoing
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-00… by Medtronic, citing 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 scre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1408-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-01-28 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic |
| Distribution | US |
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
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
Identifiers
| code_info | UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2020%22
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