FDA Medical Device Recalls (openFDA)
Ambu Inc.: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Recall number
- Z-1723-2025
- Recalling firm
- Ambu Inc.
- Product
- Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
- Status
- Open, Classified
- Initiated
- 2025-04-07
- Posted
- 2025-05-06
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 160 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
- Lot, serial or model codes
- Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963
- 510(k) numbers
- ["K232582"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 1121788
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28