Olympus Airway Mobilescope models may become lodged in connectors
Olympus Airway Mobilescope endoscopes may become lodged in endotracheal tube connectors due to oversized diameter affecting airway management procedures nationwide.
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 Class II medical device recall with a confirmed mechanical defect creating a risk of device lodgement during airway procedures. No injuries or illnesses have been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,859 units of the Olympus Airway Mobilescope, Models MAF-GM and MAF-TM (UDI-DI: 04953170340369, 04953170288661, and 04953170288630, all serial numbers). The devices are distributed nationwide in the United States.
The recall addresses a complaint that the endoscope model can become lodged in the endotracheal tube connector due to the endoscope's diameter being too large. This mechanical defect may impair proper device function.
Patients who have used this device and healthcare providers should contact Olympus Corporation of the Americas for instructions on return, replacement, or other appropriate remedial measures.
The recalled product
- Product
- Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,859
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 (4)
- UDI-DI: 04953170340369
- 04953170288661
- & 04953170288630
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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