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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/Surgical Equipment

Olympus Corporation of the Americas: UHI-4 Insufflation Unit Recalled for Sudden Air Supply Loss

Agency Publication Date: March 25, 2024
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Summary

Olympus has recalled approximately 3,172 UHI-4 Insufflation units because the device may suddenly stop providing air supply during medical procedures. This failure occurs when the front panel LED turns off unexpectedly, which has led to an increased trend of customer complaints and repair requests. This recall affects all serial numbers of the UHI-4 model. Olympus initiated this recall via a notification letter to affected domestic healthcare facilities.

Risk

If the device stops supplying air during a procedure, the patient's surgical cavity may lose pressure and collapse, potentially obstructing the surgeon's view or causing surgical delays. The sudden loss of air supply during use poses a moderate risk of injury to patients undergoing laparoscopic procedures.

What You Should Do

  1. Identify your device by checking for the model name 'UHI-4' on the front panel and verify the UDI/DI number 04953170324147.
  2. Check your device serial number; this recall affects ALL serial numbers of the UHI-4 Insufflation unit.
  3. Contact your healthcare provider or Olympus Corporation of the Americas directly at 1-800-848-9024 for further instructions and information regarding the necessary corrective actions for your device.
  4. Follow any specific guidance provided in the manufacturer's notification letter regarding the use or repair of the insufflation units.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact and assessment

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

Affected Products

Product: Insufflation unit, UHI-4
Model / REF:
UHI-4
UDI/DI: 04953170324147
Lot Numbers:
All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94080
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus authorized distributors
Manufactured In: United States
Units Affected: 3,172 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.