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Open, Classified

Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

FDA Recall Z-1382-2026 · Posted 2026-02-17

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeLFL
Date Initiated2025-10-22
Product Quantity1,538 units

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111202SURGICAL TISSUE MANAGEMENT SYSTEMOlympus Medical Systems Corp. · 2012-01-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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