Olympus Thunderbeat Grip Medical Device Recall for Adverse Events
Olympus Corporation is recalling 30 Thunderbeat 5 mm, 45 cm Inline Grips due to continued reports of adverse events during medical procedures.
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: FDA Class II medical device recall with reported adverse events, indicating a risk-of-harm product where events have been reported but no hospitalization or serious injury is specified in the source text.
Plain-English summary
Olympus Corporation of the Americas is recalling 30 units of its Olympus Thunderbeat, 5 mm, 45 cm Inline Grip medical device. The recall is being initiated due to continued reports of adverse events associated with use of the device. The affected product has model number TB-0545IC, UDI 04953170308673, and all lots are affected. The recall is worldwide, covering the United States and the countries of Brazil, Canada, Germany, Mexico, and Japan.
The recalled product
- Product
- Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 30
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-0545IC
- UDI: 04953170308673
- 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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