Olympus Bronchovideoscope models recalled for lodging risk in airway connectors
Olympus is recalling 1,715 Bronchovideoscope units across eight models due to a diameter defect that causes the device to lodge in the endotracheal tube connector.
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: This is an FDA Class II recall involving a medical device with a diameter defect that causes endoscope lodging in the endotracheal tube connector. Device entrapment during critical airway procedures presents a risk-of-harm scenario consistent with severity score 3.
Plain-English summary
Olympus Corporation of the Americas is recalling eight models of Bronchovideoscope endoscopes: BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, and BF-XT160. Approximately 1,715 units have been distributed nationwide in the United States.
The recall stems from a complaint that the endoscope becomes lodged in the endotracheal tube connector because the device diameter is too large. This mechanical fit problem can occur during clinical use.
Healthcare providers using these Bronchovideoscope models should contact Olympus Corporation of the Americas regarding this recall. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- lodging
- design-defect
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 (16)
- UDI-DI: 04953170308185
- 04953170288968
- 04953170308161
- 04953170339264
- 04953170308277
- 04953170339394
- 04953170308178
- 04953170288876
- 04953170308123
- 04953170339196
- 04953170062988
- 04953170339974
- 04953170063008
- 04953170339998
- & 04953170340147
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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