Olympus BF-XP60 Bronchofiberscope Reprocessing Instructions Updated for Validation Compliance
Olympus Corporation issued updated reprocessing instructions for the BF-XP60 bronchofiberscope to align with FDA 2015 guidance on medical device reprocessing validation and labeling.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall involves updated reprocessing instructions for a medical scope; while proper sterilization is critical to prevent contamination, the source provides no evidence of adverse events.
Plain-English summary
Olympus Corporation of the Americas has issued updated, validated reprocessing instructions for the BF-XP60 OES Bronchofiberscope, Model No. BF-XP60. The recall affects approximately 180 units distributed nationwide and globally.
The firm is issuing these validated reprocessing instructions in accordance with FDA 2015 guidance titled 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.' This update ensures that reprocessing procedures comply with current FDA standards for medical device sterilization and disinfection.
Healthcare facilities and medical centers using this device should implement the new reprocessing instructions immediately. Contact Olympus Corporation of the Americas for the updated instructions if you have not already received them.
The recalled product
- Product
- BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 180
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.
See all 10 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighOlympus BF-MP60 Bronchofiberscope Recall: Updated Sterilization and Reprocessing Instructions
FDA (Devices) · 2022-05-18
- CriticalBF-MP60 bronchofiberscopes recalled for updated instructions on therapy equipment use
FDA (Devices) · 2025-10-22
- CriticalBF-P60 bronchofiberscopes recalled for updated instructions on laser and coagulation use
FDA (Devices) · 2025-10-22
- HighBronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns
FDA (Devices) · 2022-05-18
- CriticalBF-1T60 bronchofiberscopes recalled for updated instructions on energy therapy equipment
FDA (Devices) · 2025-10-22
- CriticalBF-XT40 bronchofiberscopes recalled for updated therapy equipment use instructions
FDA (Devices) · 2025-10-22