Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number...
FDA Device Recall #Z-0261-2025 — Class II — September 16, 2024
Recall Summary
| Recall Number | Z-0261-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 16, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ambu Inc. |
| Location | Columbia, MD |
| Product Type | Devices |
| Quantity | 1824 |
Product Description
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Reason for Recall
Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.
Distribution Pattern
US Nationwide. Canada.
Lot / Code Information
Lot Codes: VivaSight 2 DLT Kit 35 Fr - lot no. 1000891667 to lot. no 1001021855; VivaSight 2 DLT Kit 37 Fr - lot. no. 1000887909 to lot no. 1001021861; VivaSight 2 DLT Kit 39 Fr - lot. no. 1000916871 to lot no. 1001021917; VivaSight 2 DLT Kit 41 Fr - lot. no. 1000934084 to lot. no. 1001011434
Other Recalls from Ambu Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2181-2025 | Class I | Ambu SPUR II Labeled as the following: 1 SPUR I... | Jul 9, 2025 |
| Z-1723-2025 | Class II | Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. ... | Apr 7, 2025 |
| Z-0714-2024 | Class II | Ambu aView 2 A Monitor, Catalog numbers 4050110... | Dec 5, 2023 |
| Z-2628-2023 | Class II | Ambu aView 2 A Monitor-The Ambu aView 2 Advance... | Jul 21, 2023 |
| Z-1420-2022 | Class II | Ambu VivaSight 2 DLT; endobronchial tube system... | Jun 3, 2022 |
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.