CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

aScope" 5 Broncho HD 5.6/2.8 Sampler Set recalled by Ambu

Ambu is recalling aScope" 5 Broncho HD 5.6/2.8 Sampler Set, distributed nationwide in the US. The recall was initiated on 7 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

Quantity recalled160 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1723-2025
FDA event ID: 96649
Recalling firm: Ambu, Columbia, MD
Classification: Class II
Status: Ongoing
Recall initiated: 7 Apr 2025
FDA classified: 6 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

7 Apr 2025	Recall initiated by company
6 May 2025	Classified by FDA	+29 days
14 May 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.

Nationwide California Colorado Florida Georgia Kentucky Maryland Montana New Jersey Nevada Pennsylvania Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Number: 622002000US. UDI-DI: 05707480156542. Lot Number: 1001080963

Where was it sold?

US Nationwide distribution in the states of CA, CO, FL, GA, KY, MD, MT, NJ, NV, PA, TN, TX, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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