Ambu aScope 5 Broncho HD Endoscope Labeling Error Recall
Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set due to incorrect front pouch labeling that states 5.0/2.2 instead of the correct size 5.6/2.8.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error with no reported illnesses or injuries. The hazard is a discrepancy between front and back labeling that could cause confusion about device specifications, which qualifies as a moderate-risk labeling issue under the rubric.
Plain-English summary
Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set (Model Number 622002000US, UDI-DI: 05707480156542, Lot Number: 1001080963) due to incorrect labeling on the front red pouch. The front label incorrectly states the device size as 5.0/2.2, while the back label, shipping box, and product inside correctly identify the size as 5.6/2.8.
The product was distributed nationwide in California, Colorado, Florida, Georgia, Kentucky, Maryland, Montana, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, and Virginia. The labeling discrepancy could lead to confusion about the actual device specifications. Customers who have received this product should verify the correct size (5.6/2.8) on the back label, shipping box, or product itself rather than relying on the incorrect front pouch label.
The recalled product
- Product
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Manufacturer
- Ambu Inc.
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Distribution
Related recalls
Same manufacturer · Ambu Inc.
See all →- CriticalManual resuscitators recalled because blocked manometer port may disable pressure gauge
FDA (Devices) · 2025-08-20
- HighAmbu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk
FDA (Devices) · 2024-11-06
- HighAmbu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws
FDA (Devices) · 2024-01-17
- HighAmbu aView 2 Advance Monitor Recalled Due to Battery Combustion Risk
FDA (Devices) · 2023-10-04
- HighAmbu VivaSight 2 DLT endobronchial tubes recalled for cuff leak risk
FDA (Devices) · 2022-07-27
Same hazard · mis labeling
See all →- HighByron White Herbal Supplement Recalled for Undeclared Walnut Allergen
FDA (Food) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02