Recall Z-1372-2026 ยท LFL Instrument, Ultrasonic Surgical
Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
| Date | Feb 17, 2026 (initiated Oct 22, 2025) |
| Status | Open, Classified |
| 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 | 88,268 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172610 | THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 Olympus Medical Systems Corp., Apr 17, 2018 |