Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
FDA device recall Z-1372-2026 · posted 2026-02-17 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Firm is initiating a removal due to continued reports of adverse events.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LFL
- Quantity affected
- 88,268 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Date initiated
- 2025-10-22
- Date posted
- 2026-02-17
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (K172610) | Olympus Medical Systems Corp. | 2018-04-17 |