Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 84...
FDA Device Recall #Z-1618-2020 — Class II — December 6, 2019
Recall Summary
| Recall Number | Z-1618-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 6, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Karl Storz Endoscopy |
| Location | El Segundo, CA |
| Product Type | Devices |
| Quantity | 27,165 scopes |
Product Description
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
Reason for Recall
The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.
Distribution Pattern
Worldwide distribution - US Nationwide and country of Canada.
Lot / Code Information
All Lots
Other Recalls from Karl Storz Endoscopy
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1062-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureterosco... | Dec 19, 2024 |
| Z-1052-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Ure... | Dec 19, 2024 |
| Z-1051-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Ure... | Dec 19, 2024 |
| Z-1055-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Re... | Dec 19, 2024 |
| Z-1057-2025 | Class II | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Re... | Dec 19, 2024 |
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.