Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk
Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged 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 a risk-of-harm medical device where the endoscope may become lodged in the airway connector, potentially compromising patient safety. No illnesses or injuries have been reported, which aligns with FDA Class II classification and the rubric criterion for High severity.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Bronchovideoscope Models BF-1T180, BF-1TQ180, BF-P180, and BF-Q180. These devices were distributed nationwide in the United States, with approximately 3,652 units affected.
The recall was issued due to complaints that the endoscope diameter is oversized, creating a risk that the endoscope may become lodged in the endotracheal tube connector during clinical use.
Healthcare facilities and providers who use these bronchovideoscopes should stop using the affected models immediately. Patients who received care using these devices should consult their healthcare provider if they have concerns. The manufacturer recommends contacting Olympus Corporation of the Americas for instructions on device return or replacement.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Hazard
- device-lodging
- airway-obstruction
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 (13)
- UDI-DI: 04953170308215
- 04953170288975
- 04953170339325
- 04953170308222
- 04953170289002
- 04953170339349
- 04953170308192
- 04953170317965
- 04953170339288
- 04953170288883
- 04953170308208
- 04953170288937
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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