Recall Z-1723-2025— Ambu Inc.
Class II · Ongoing
Class II FDA medical device recall by Ambu Inc., initiated 2025-04-07. It names one FDA 510(k) clearance: K232582. Product: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US. Reason: 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..
- Recalling firm
- Ambu Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-07
- Firm location
- Columbia, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.