The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · fire

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