Olympus Bronchovideoscope Models Recalled Due to Lodging Risk in Connectors
Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.
What this means for you
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 of a medical device with a documented risk of device lodging in a critical connector during clinical use. Per the severity rubric, risk-of-harm medical device defects score at High (3) severity.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,072 units of Bronchovideoscope, Models BF-MP160F, BF-XP160F, and BF-XP60, distributed nationwide. A bronchovideoscope is a medical endoscope used during bronchoscopy procedures to visualize the lungs and airways.
The recalled devices can become lodged in the endotracheal tube connector because the endoscope diameter is too large. This creates a risk of device entrapment during bronchoscopy procedures.
Healthcare facilities using these models should contact their Olympus service representative for further instructions.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- device-lodging
- entrapment-hazard
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 (8)
- UDI-DI: 04953170340048
- 04953170289064
- 04953170340093
- 04953170289033
- 04953170340116
- 04953170308154
- & 04953170339240
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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