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U.S. Department of Health and Human Services

Class 2 Device Recall aScope 5 Broncho HD 5.6/2.8 Sampler Set

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 Class 2 Device Recall aScope 5 Broncho HD 5.6/2.8 Sampler Setsee related information
Date Initiated by FirmApril 07, 2025
Date PostedMay 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1723-2025
Recall Event ID 96649
510(K)NumberK232582 
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
ProductAmbu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Code Information Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
FEI Number 1121788
Recalling Firm/
Manufacturer		 Ambu Inc.
6721 Columbia Gateway Dr Ste 200
Columbia MD 21046-3380
For Additional Information ContactSanjay Parikh
410-768-6464
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionAmbu 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.
Quantity in Commerce160 units
DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EOQ
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