Olympus Thunderbeat 5 mm 45 cm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 45 cm Front-Actuated Grip devices due to reports of adverse events.
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: The device is subject to an FDA Class II recall involving reports of adverse events, which represents a risk of harm without reported illness or injury in the source text.
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip (Model No. TB-0545FC; UDI: 04953170337543; All Lots) due to continued reports of adverse events.
This recall affects products distributed worldwide, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
Users should follow the manufacturer's instructions regarding the removal of these devices.
The recalled product
- Product
- Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
- Manufacturer
- Olympus Corporation of the Americas
- 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 (3)
- Model No. TB-0545FC
- UDI: 04953170337543
- All Lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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