Class I U.S. Food and Drug Administration

Olympus High Flow Insufflation Unit recall: Issue with software algorithm which may lead to overpressure events

Recall published 8 months ago

Issue with software algorithm which may lead to overpressure events.

The hazard: Fire or burn hazard

This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

What the notice says: Issue with software algorithm which may lead to overpressure events.

Why it matters: The product can overheat, ignite or cause a burn. Where lithium batteries are involved the failure is fast and very hot, and water does not put it out quickly.

Symptoms and when to call a doctor

Treat a burn by cooling it under running water for about 20 minutes — not with ice, butter or ointment — and cover it loosely with a clean non-fluffy cloth. Get medical help for burns that are larger than the person’s palm, that are deep or white or charred, that involve the face, hands, feet or genitals, or any burn to a baby or young child. If someone has inhaled smoke and is coughing, hoarse or short of breath, call 911.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1352-2026
Published
February 25, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Olympus Corporation of the Americas
Product type
Medical devices
Units affected
18 units
Distribution
Nationwide
Made in
United States
Lot / code info
Model Number: UHI; UDI-DI: N/A; All Serial Numbers

Products covered by this recall

Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • UHI

Serial number

On the rating plate, often next to the date of manufacture.

  • s — 18 units

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fire

Olympus Corporation of the Americas — This product can overheat or catch fire, which is why the instruction is to unplug and stop using it rather than to keep an eye on it.

  1. Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.
  2. Do not leave it charging overnight or while the house is empty while you wait for the remedy.
  3. If it has already overheated, scorched or swelled, do not keep using it and do not try to repair it.
  4. Check that your smoke alarms work while you are thinking about it, and follow the remedy on this page.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.

Company contact: Olympus Corporation of the Americas — 3500 Corporate Pkwy, Center Valley, PA, 18034-8229

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus Corporation of the Americas medical devices recalled?

Issue with software algorithm which may lead to overpressure events. Issue with software algorithm which may lead to overpressure events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number UHI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using it and unplug it from the wall. If it runs on a battery pack, stop charging it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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