Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model… recallZ-1723-2025 · Ambu Inc. · initiated Apr 7, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ambu Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Ambu notified sales representative first on 04/07/2025 with an "Urgent Field Safety Notice" letter and they are instructed to visit the affected accounts to notify them of the recall. The letter instructs customers to identify and quarantine any affected units on hand, to arrange for the return of affected units or destroy them on site, and to complete and return the response form.
Recall details
- Recall number
- Z-1723-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 7, 2025
- Posted by the FDA
- May 6, 2025
- Recalling firm
- Ambu Inc.
- Quantity
- 160 units
- Product code
- EOQ
- FDA submissions
- K232582
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Product description
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Code information (models, lots, serial numbers)
Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- aScope™ 5 Broncho HD 5.6/2.8 Sampler Set 622002000USAmbu A/S · Bronchoscope (flexible or rigid)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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