Olympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance
Olympus Corporation has issued new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope to comply with FDA guidance. The recall affects 1,030 devices distributed nationwide and internationally.
What this means for you
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 a Class II device recall with no reported illnesses or injuries. The hazard is theoretical and related to proper reprocessing procedures. The firm is proactively issuing corrective instructions, consistent with a voluntary precautionary recall classified as Moderate per the rubric.
Plain-English summary
The BF-P60 OES Bronchofiberscope is a medical device manufactured by Olympus Corporation of the Americas. A total of 1,030 units have been distributed domestically nationwide and internationally, with all serial numbers included in this recall action.
Olympus Corporation is issuing new, validated reprocessing instructions for the BF-P60 OES Bronchofiberscope in accordance with FDA 2015 guidance on reprocessing medical devices in health care settings. The new instructions address validation methods and labeling requirements as outlined in the FDA guidance.
Healthcare facilities and healthcare providers using the BF-P60 OES Bronchofiberscope should obtain and implement the new reprocessing instructions provided by Olympus Corporation. Staff responsible for device reprocessing should be trained on the updated instructions to ensure proper handling and maintenance of the device.
The recalled product
- Product
- BF-P60 OES Bronchofiberscope, Model No. BF-P60
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,030
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 Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
Same hazard · improper reprocessing
See all →- HighKarl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
FDA (Devices) · 2024-10-02
- HighFDA Recalls Karl Storz Endoscopes Due to Unapproved Reprocessing Instructions
FDA (Devices) · 2024-10-02
- HighDisposable 5 Lead Cable System May Contain Non-Approved ECG Leads
FDA (Devices) · 2024-08-28
- ModerateOlympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated
FDA (Devices) · 2021-10-06
- High