BF-TE2 bronchofiberscopes recalled for clarified instructions on therapy equipment use
Olympus is recalling Bronchofiberscope BF Type TE2 units for instructions-for-use updates on safe use with laser, argon plasma coagulation and high-frequency therapy equipment.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 TE2, model BF-TE2, 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 one unit in the United States and 5,286 outside it, across all serial numbers, UDI 4953170339998. 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 TE2
- 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-TE2
- UDI: 4953170339998
- 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.
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