Olympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 indicates a risk of harm without confirmed 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, 35 cm, Front-Actuated Grip Type S. This action is being taken following continued reports of adverse events.
The affected products include Model No. TB-0535FCS (UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540) across all lots. The distribution is worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
Users should follow manufacturer instructions regarding the removal of these units.
The recalled product
- Product
- Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 88,268
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 (6)
- Model No. TB-0535FCS
- UDI: 04953170383564
- 04953170383557
- 04953170409677
- 04953170383540
- 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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