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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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