Olympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 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 product is subject to an FDA Class II recall involving adverse events, which indicates a risk of harm without specific reports of serious injury or death in the provided text.
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip. This action is being taken following continued reports of adverse events.
The affected products include Model TB-0520FC with UDI numbers 04953170370519 and 04953170370502, as well as all other lots. This recall involves worldwide distribution, 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, 20 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 (4)
- Lot Code: Model: TB-0520FC
- UDI: 04953170370519
- 04953170370502
- 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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