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Z-1375-2026Class II
Olympus Corporation of the Americas
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Olympus Corporation of the Americas
Product type
Device
Status
Ongoing
Report date
2026-02-25
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Firm state
PA
Product quantity
0 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Firm is initiating a removal due to continued reports of adverse events.
Product description
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Code / lot info
Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →