[pending] Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Pending LLM rewrite. Source: FDA_DEVICE Z-1723-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
The recalled product
- Product
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Manufacturer
- Ambu Inc.
- Category
- Medical Device — Devices
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.
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