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Recall Observatory FDA recall evidence

Device product

Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

Z-1377-2026

October 22, 2025

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 98188
Status
Ongoing
Classification
Class II
Quantity
30 units
Official record key
device-enforcement:Z-1377-2026

Official wording

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

Code information: Model No. TB-0545PC; UDI: 04953170308635; All Lots.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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