Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
FDA device recall Z-1723-2025 · posted 2025-05-06 · Open, Classified
Recall details
- Recalling firm
- Ambu Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 160 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
- Date initiated
- 2025-04-07
- Date posted
- 2025-05-06
- Location
- Columbia, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K232582) | Ambu A/S | 2023-09-20 |