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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Ambu Inc.: aView 2 Advance Monitor Recalled for Fire and Smoke Risk

Agency Publication Date: September 22, 2023
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Summary

Ambu Inc. is recalling 2,689 units of the Ambu aView 2 Advance Monitor, a portable endoscopy display system. The device can short-circuit if it is subjected to multiple impacts, such as being dropped. This short-circuit can cause the internal lithium-ion battery to combust, leading to smoke and flames. Affected monitors were manufactured prior to October 29, 2020.

Risk

Multiple impacts to the monitor can damage internal components and cause a short-circuit. Under certain conditions, this triggers the lithium-ion battery to catch fire or emit smoke, posing a serious risk of fire, burns, and smoke inhalation to patients and healthcare providers.

What You Should Do

  1. Locate your Ambu aView 2 Advance Monitor and check the version number and manufacturing date on the device label.
  2. Identify if your device is affected by looking for Version numbers 054 through 056 or 058 through 059 that were manufactured prior to October 29, 2020.
  3. Verify the Unique Device Identifier (UDI) number 5707480145089 and Catalog Number 405011000 to confirm a match.
  4. Contact your healthcare provider or Ambu Inc. at 1-800-262-8462 for further instructions regarding the safety of your specific unit and potential remedy options.
  5. For additional information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Ambu aView 2 Advance Monitor
Model / REF:
Catalog No: 405011000
Version no.: 054
Version no.: 055
Version no.: 056
Version no.: 058
Version no.: 059
Lot Numbers:
UDI: 5707480145089
Date Ranges: Manufactured prior to Oct 29, 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92886
Status: Active
Manufacturer: Ambu Inc.
Sold By: Ambu Inc.
Manufactured In: United States
Units Affected: 2689 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.