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Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip recallZ-1375-2026 · Olympus Corporation of the Americas · initiated Oct 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firm is initiating a removal due to continued reports of adverse events.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE PRODUCT REMOVAL notification was mailed to consignees on 12/22/25. The notification instructs consignees to examine inventory for affected devices, immediately cease use and quarantine devices, and contact Customer Service at 1-800-848-9024 (option 2) to obtain a Return Materials Authorization. Credit will be issued to consignees upon return of devices. If product has been further distributed, consignees are to forward the provided notification. Consginees with any questions can contact Cynthia Ow at [email protected] or by phone at 674-999-3203.

Recall details

Recall number
Z-1375-2026
Status
Open, Classified
Initiated by the company
Oct 22, 2025
Posted by the FDA
Feb 17, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
0 units
Product code
LFL
FDA submissions
K111202
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Product description

Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

Code information (models, lots, serial numbers)

Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 98188).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page