CLASS II ONGOING Device recall · Reported 27 Jul 2022 · FDA Enforcement Report
VivaSight 2 DLT recalled by Ambu
Ambu is recalling VivaSight 2 DLT, distributed nationwide in the US. The recall was initiated on 3 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1420-2022
- FDA event ID
- 90488
- Recalling firm
- Ambu, Columbia, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2022
- FDA classified
- 20 Jul 2022
- Reported
- 27 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2022 | Recall initiated by company | |
| 20 Jul 2022 | Classified by FDA | +47 days |
| 27 Jul 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
Where it was distributed
Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Domestic distribution nationwide. Foreign distribution to Austria, Belgium, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norge, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, UK Canada, Australia, New Zealand, Israel .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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