The Recall Desk
SevereFDA (Devices)·Z-0054-2026·Announced 2025-10-22

Olympus Bronchofiberscope Class I Recall for Instructions-for-Use Clarification

Olympus Corporation is recalling 59 BF-MP60 bronchofiberscopes distributed in the US due to the need for clarification in instructions for use with laser, argon plasma coagulation, and high-frequency therapy equipment.

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 recall, which per the rubric requires a minimum severity of 4 (Severe). Although no injuries or illnesses are reported, the FDA's classification indicates a serious potential hazard related to the device's use with specific therapeutic equipment.

Plain-English summary

Olympus Corporation of the Americas is recalling the OES Bronchofiberscope Olympus BF Type MP60 (Model No. BF-MP60) under FDA Class I classification. A total of 59 units have been distributed in the United States and 665 units outside the United States.

The recall was initiated to provide additional clarification in the instructions for use (IFU) addressing safe and effective use of the bronchoscope when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

The recalled product

Product
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopy / Bronchoscopy
Hazard
  • device-interaction
  • improper-use

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. BF-MP60
  • UDI: n/a
  • All Serial No.

Distribution

Distributed nationwide across the United States.

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