Agency classClass IIOur severity:High FDA (Devices)·Z-1046-2022·Announced 2022-05-18

Olympus BF-MP60 Bronchofiberscope Recall: Updated Sterilization and Reprocessing Instructions

Olympus is updating instructions for reprocessing and sterilizing BF-MP60 bronchofiberscopes to ensure proper procedures. All 60 units distributed nationwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device (respiratory endoscope) where improper sterilization and reprocessing could lead to cross-contamination and patient infection. Although no illnesses or injuries have been reported, the critical nature of proper device reprocessing and sterilization for patient safety justifies a High severity rating.

Plain-English summary

Olympus Corporation of the Americas is issuing updated instructions for the BF-MP60: OES Bronchofiberscope, a respiratory medical device. The update addresses procedures for chemical use during device reprocessing, conditions for ethylene oxide (ETO) gas sterilization, rinsing steps following high-level disinfection, and sterilization recommendations.

Approximately 60 units of this device have been distributed nationwide in the United States. All serial numbers are affected by this instruction update, as identified by UDI 04953170339394.

Healthcare facilities and medical professionals using this device should review and implement the updated instructions to ensure proper reprocessing and sterilization procedures are followed. Adherence to proper sterilization and reprocessing protocols is essential to prevent cross-contamination and ensure patient safety.

The recalled product

Product: BF-MP60: OES Bronchofiberscope
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Respiratory Endoscope
Hazard: improper-sterilization
cross-contamination
infection-risk
Affected units: 60

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 (1)

All serial numbers. UDI: 04953170339394

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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