Z-1723-2025Class II

Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US

Name: Z-1723-2025 Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Creator: Ambu Inc.
Published: 2025-04-07
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2025-04-07 / Open, Classified / root cause: manufacturing process

FDA source

Ambu Inc. began a recall of Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US on 2025-04-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1723-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-07
Posted: 2025-05-06
Recalling firm: Ambu Inc.
Product: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 160 units
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.
Product codes and lots: Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1723-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1723-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-06

Product code EOQ

K232582Class IIAmbu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S / cleared 2023-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)