Class II — Medtronic, PLC
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| 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. |
| Quantity | 109,897 |
| 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, Norw… |
| Initiated | 2020-01-28 |
| Classified | 2020-02-28 |
| Recall number | Z-1408-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic, PLC (Z-1408-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84819/
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