BF-PE2 bronchofiberscopes recalled for updated instructions on energy therapy equipment
Olympus is recalling Bronchofiberscope BF Type PE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
The Bronchofiberscope Olympus BF Type PE2, model BF-PE2, is being recalled for additional instructions-for-use updates.
The updates provide further clarification on the safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation and high-frequency therapy equipment.
The recall covers two units in the United States and 4,289 outside it, across all serial numbers, UDI 4953170339974. Distribution was nationwide in the United States. The FDA has classified the recall as Class I.
Bronchoscopy units should obtain and follow the updated instructions for use before combining these scopes with the listed energy equipment.
The recalled product
- Product
- BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Bronchoscope
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-PE2
- UDI: 4953170339974
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 23 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 23 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 · labeling update
See all →- ModerateFoot plating systems recalled to remove a sterilization option from instructions
FDA (Devices) · 2025-10-29
- CriticalBF-H1100 bronchovideoscopes recalled for updated instructions on energy therapy equipment
FDA (Devices) · 2025-10-22
- CriticalBF-1TQ180 bronchovideoscopes recalled for updated therapy equipment use instructions
FDA (Devices) · 2025-10-22
- CriticalBF-1TH1100 bronchovideoscopes recalled for updated instructions on energy therapy equipment
FDA (Devices) · 2025-10-22
- CriticalBF-P60 bronchofiberscopes recalled for updated instructions on laser and coagulation use
FDA (Devices) · 2025-10-22
Similar recalls
- SevereOlympus Bronchofiberscope BF Type recalled for combustion risk during laser procedures
FDA (Devices) · 2023-07-26
- ModerateOlympus BF-P60 Bronchofiberscope Reprocessing Instructions Updated to Meet FDA Guidance
FDA (Devices) · 2021-10-06
- SevereOlympus OES Bronchofiberscope Models Recalled for Combustion Risk During Laser Procedures
FDA (Devices) · 2023-07-26
- HighOlympus BF-3C40 OES Bronchofiberscope Recall: Reprocessing Instructions Updated
FDA (Devices) · 2021-10-06
- ModerateOlympus BF-XP60 Bronchofiberscope Reprocessing Instructions Updated for Validation Compliance
FDA (Devices) · 2021-10-06
- SevereOlympus Bronchoscope Recall: Risk of Combustion During Laser Procedures
FDA (Devices) · 2023-07-26