Ambu VivaSight 2 DLT — Class II medical device recall Z-1420-2022
Ongoing recall by Ambu Inc., reported 2022-07-27, distributed nationwide. Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. L
| Recall number | Z-1420-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ambu Inc., Columbia, MD, United States |
| Recall initiated | 2022-06-03 |
| Classified | 2022-07-20 |
| Reported by FDA | 2022-07-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, IT, LU, NL, NZ, PL, PT, RO, SE, SI, SK |
| Quantity | 12,921 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05707480145706, 05707480145713, 05707480145737, 05707480145744, 05707480145768, 05707480145775, 05707480145799, 05707480145805 |
| Model numbers | 412351000, 412371000, 412391000, 412411000 |
Product
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1420-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.