Ambu Inc. is recalling 160 units of the Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set (Model 622002000US) because the size printed on the front label of the package is incorrect. While the front label incorrectly lists the size as 5.0/2.2, the back label, shipping box, and the actual product inside are correctly identified as size 5.6/2.8. No incidents or injuries have been reported, but the mismatch could lead to the wrong device being selected for a medical procedure.
Incorrect size labeling can lead to a clinician using a device that is larger or smaller than intended for a patient's airway. This could result in procedural delays or technical difficulties during a bronchoscopy if the device does not fit the intended space or compatible accessories.
Recall #: Z-1723-2025. Incorrect labeling on front red pouch label (states 5.0/2.2 instead of 5.6/2.8).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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