Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Device Recall #Z-0144-2024 — Class I — September 28, 2023
Recall Summary
| Recall Number | Z-0144-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | September 28, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien |
| Location | Boulder, CO |
| Product Type | Devices |
| Quantity | 5709 |
Product Description
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Reason for Recall
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
Distribution Pattern
Unknown
Lot / Code Information
Stolen defective products are not appropriately packaged and labeled - Some are missing serial numbers. UDI-DI: 10884521776494, 20884521823393. Known Affected Serial Numbers: 000063, 000076, 000085, 000092, 000093, 000112, 000120, 000121, 000146, 000153, 000154, 000155, 000166, 000179, 000190, 000197, 000202, 000224, 000233, 000238, 000255, 000308, 000329, 000375, 000389, 000436, 000446, 000455, 000464, 000465, 000497, 000512, 000526, 000528, 000546, 000553, 000597, 000607, 000628, 000641, 000648, 000650, 000673, 000677, 000745, 000752, 000753, 000760, 000764, 000769, 000781, 000809, 000810, 000821, 000823, 000847, 000850, 000871, 000879, 000887, 000891, 000913, 000914, 000918, 000939, 000958, 000960, 001015, 001027, 001135, 001140, 001191, 001211, 001348, 001355, 001385, 001418, 001446, 001491, 001504, 001534, 001555, 001561, 001596, 001605, 001621, 001629, 001631, 001669, 001760, 001826, 001829, 001859, 001952, 001985, 002008, 002016, 002017, 002037, 002042, 002056, 002151, 002160, 002174, 002197, 002234, 002242, 002279, 002282, 002291, 002294, 002321, 002322, 002363, 002386, 002480, 002676, 002777, 002780, 002786, 002793, 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| Z-2717-2024 | Class II | Covideien McGRATH MAC Video Laryngoscope, REF: ... | Jul 9, 2024 |
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.