Olympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated
Olympus is recalling approximately 484 BF-3C40 OES Bronchofiberscopes due to reprocessing instruction updates. The manufacturer is issuing validated instructions per FDA 2015 guidance for proper device reprocessing.
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: FDA Class II recall addressing reprocessing instruction procedures for an invasive medical device used in respiratory procedures. Although no illnesses or injuries have been reported, improper reprocessing of bronchofiberscopes poses patient infection risk, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Olympus Corporation of the Americas is recalling approximately 484 BF-3C40 OES Bronchofiberscopes with all serial numbers distributed nationwide and globally. The recall addresses reprocessing procedures for this bronchofiberscope model.
Olympus is issuing validated reprocessing instructions developed in accordance with the FDA's 2015 guidance document titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." These instructions specify proper methods for cleaning, sterilizing, and preparing the device for clinical use.
Hospitals, clinics, and other healthcare providers using the BF-3C40 OES Bronchofiberscope should obtain and follow the validated reprocessing instructions from Olympus Corporation. Proper implementation of these procedures is important for ensuring device safety and efficacy in patient care settings.
The recalled product
- Product
- BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 484
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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.
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