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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Thunderbeat 5 mm, 35 cm, FrontActuated Grip

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 Class 2 Device Recall Olympus Thunderbeat 5 mm, 35 cm, FrontActuated Gripsee related information
Date Initiated by FirmOctober 22, 2025
Date PostedFebruary 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1375-2026
Recall Event ID 98188
510(K)NumberK111202 
Product Classification Instrument, ultrasonic surgical - Product Code LFL
ProductOlympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Code Information Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Firm is initiating a removal due to continued reports of adverse events.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 in Commerce0 units
DistributionWorldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LFL
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