Agency classClass IOur severity:Severe FDA (Devices)·Z-2012-2023·Announced 2023-07-26

Olympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures

Olympus bronchoscopes (Models BF-PE2 and BF-TE2) are recalled due to reports of combustion inside the airway during laser-assisted medical procedures. This is an FDA Class I recall.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall, which requires a minimum severity score of 4 per the rubric. The hazard—endobronchial combustion during therapeutic laser procedures—creates a direct fire and burn risk during invasive medical procedures, though no patient injuries or deaths are documented in the source.

Plain-English summary

Olympus Corporation of the Americas is recalling Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2 and BF-TE2. These are diagnostic bronchoscopes used by physicians to visualize the airways during medical procedures.

The FDA has classified this as a Class I recall due to complaints of endobronchial combustion—fire or burning within the airway—occurring during therapeutic laser procedures using these devices. Combustion during a medical procedure poses a serious risk of harm to patients.

This recall affects 4 units distributed nationwide in the United States. Healthcare facilities and providers should identify any affected devices and cease using them for laser-assisted procedures until further instruction.

Patients or providers who have questions about this recall should contact Olympus Corporation of the Americas. The FDA has assigned this recall the number Z-2012-2023 for reference.

The recalled product

Product: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Diagnostic/Surgical Instruments
Hazard: fire
burn-injury
Affected units: 4

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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