Ambu aScope 5 Broncho HD Bronchoscope Sampler Set Labeling Error
Ambu aScope 5 Broncho HD Sampler Set units have incorrect front label specifications. The front label lists 5.0/2.2 while the device is actually 5.6/2.8 as correctly labeled on the back.
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 a Class II medical device recall involving a labeling error with no reported illnesses or injuries. The source text indicates the discrepancy is limited to the front label, with correct specifications present on the back label and shipping box.
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) due to incorrect labeling on the front of the product packaging.
The front red pouch label on the affected units incorrectly states the device specifications as 5.0/2.2, while the actual device is 5.6/2.8. The back label, shipping box, and product inside all correctly state the actual specifications of 5.6/2.8.
The recalled units were distributed nationwide in California, Colorado, Florida, Georgia, Kentucky, Maryland, Montana, New Jersey, Nevada, Pennsylvania, Tennessee, Texas, and Virginia. The affected lot number is 1001080963.
If you have received one of these products, verify the device specifications against the back label and shipping box documentation to confirm you have the correct specifications before clinical use.
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
- mislabeling
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
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03