FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- Recall number
- Z-1381-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- Status
- Open, Classified
- Initiated
- 2025-10-22
- Posted
- 2026-02-17
- Terminated
- not on file
- Reason
- Firm is initiating a removal due to continued reports of adverse events.
- Root cause
- Under Investigation by 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 Cynthia.Ow@Olympus.com or by phone at 674-999-3203.
- Quantity
- 140 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Lot, serial or model codes
- Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots.
- 510(k) numbers
- ["K111202"]
- PMA numbers
- not on file
- Product code
- LFL
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28