Ambu Inc. Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Brand
Ambu Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalog No: 412351000 UDI-DI: 5707480145706 1 each 5707480145713 5 pc/pack Catalog No. 412371000 UDI-DI: 5707480145737 1 each 5707480145744 5 pc/pack Catalog No. 412391000 UDI-DI: 5707480145768 1 each 5707480145775 5 pc/pack Catalog No. 412411000 UDI-DI: 5707480145799 1 each 5707480145805 5 pc/pack All lots
Ambu Inc. is recalling Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. due to Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to lo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
Recommended Action
Per FDA guidance
On June 3, 2022, the firm notified customers of the recall through email. Customers were instructed to discard their affected product and report the amount back to the firm. The firm will provide replacement product or credit to affected customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026