Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- Recall Initiated
- October 22, 2025
- Posted
- February 17, 2026
- Recall Number
- Z-1381-2026
- Quantity
- 140 units
- Firm Location
- Center Valley, PA
Reason for Recall
Firm is initiating a removal due to continued reports of adverse events.
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Lot / Code Info
Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots.
Root Cause
Under Investigation by firm
Action Taken
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.