Class II U.S. Food and Drug Administration

Olympus Bronchofiberscopes and bronchovideoscopes recall: Potential for endobronchial combustion

Recall published 12 months ago

Potential for endobronchial combustion

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0872-2026, Z-0873-2026, Z-0874-2026
Published
October 31, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Olympus
Product type
Medical devices
Units affected
6578 units
Distribution
Nationwide
Lot / code info
Model: OER-Elite; UDI: 04953170404047; Serial #: All; — Model: OER-Pro; UDI: 04953170258589; Serial #: All; — Model: OER-Mini; UDI: 04953170331619; Serial #: All;
UPC codes
04953170404047, 04953170258589, 04953170331619

Products covered by this recall

Bronchofiberscopes and bronchovideoscopes

What the company announced

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree.

This corrective action supersedes the previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Since the Field Corrective Action in 2023, Olympus conducted additional assessment on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Customers were notified of the instructions for use updates through a September 2025 letter and are asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes.

Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations: ensuring there is separation of >4cm between the endoscope and the endotracheal tube; oxygen levels of less than 40%; energy output of less than 40 watts; avoiding excessive energy applied to one spot; and the use of suction to evacuate smoke.

There is a risk of endobronchial combustion if laser therapy, argon plasma coagulation, or high-frequency cauterization is performed while supplying oxygen in excess of 40% and/or the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

If endobronchial combustion occurs, patients may suffer critical internal burns to the airway or lungs that may result in a requirement for additional medical intervention, prolonged procedure, extended hospitalization or ICU care, and death. Combustion can also result in damage to or breakage of device components that may injure or remain unintendedly in the patient and/or may require retrieval or surgical removal.

Note: Olympus advises users to consult the respective instructions for use for devices that may be used with Olympus bronchoscopes.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda .

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email [email protected] .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04953170404047
  • 04953170258589
  • 04953170331619

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

What to do about Device

Olympus — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Olympus Corporation — Consumers: (800) 848-9024, [email protected]

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus medical devices recalled?

Potential for endobronchial combustion Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04953170404047, 04953170258589, 04953170331619. 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?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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