FDA recall, , Moderate risk
Olympus Thunderbeat Surgical Devices
Firm is initiating a removal due to continued reports of adverse events.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, initiated a removal on October 22, 2025, due to continued reports of adverse events. The action, added to the FDA's Enforcement Report on February 17, 2026, covers multiple models of the Olympus Thunderbeat, including 5 mm, 45 cm Front-Actuated Grip Type S and 5 mm, 20 cm Front-Actuated Grip Type S, among others.
The products were distributed worldwide, including US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
12 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
- UDI-DI
- 04953170370519
- 04953170370502
- Lot code
- TB-0520FC
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
- UDI-DI
- 04953170308635
- Lot code
- Model No. TB-0545PC; UDI: 04953170308635; All Lots.
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
- UDI-DI
- 04953170383533
- 04953170383526
- 04953170409684
- 04953170383519
- Lot code
- Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
- UDI-DI
- 04953170383571
- 0495317083595
- 04953170383588
- Lot code
- Model No. TB-0520FCS; UDI: 04953170383571, 0495317083595, 04953170383588; All Lots.
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
- UDI-DI
- 04953170308673
- Lot code
- Model No. TB-0545IC; UDI: 04953170308673; All Lots.
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
- UDI-DI
- 04953170308581
- 04953170608710
- Lot code
- Model No. TB-0520IC; UDI: 04953170308581, 04953170608710; All Lots.
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
- UDI-DI
- 04953170308734
- Lot code
- Model No. TB-0510IC; UDI: 04953170308734; All Units.
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
- UDI-DI
- 04953170337574
- 04953170464959
- Lot code
- Model No. TB-0535FC; UDI: 04953170337574, 04953170464959; All Lots.
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
- UDI-DI
- 04953170464973
- Lot code
- Model No. TB-0535IC; UDI: 04953170464973; All Lots.
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
- UDI-DI
- 04953170337543
- Lot code
- Model No. TB-0545FC; UDI: 04953170337543; All Lots.
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
- UDI-DI
- 04953170383564
- 04953170383557
- 04953170409677
- 04953170383540
- Lot code
- Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots.
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
- UDI-DI
- 04953170308659
- Lot code
- Model No. TB-0535PC; UDI: 04953170308659; All Lots.
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98188
- Recall numbers
- Z-1371-2026 to Z-1382-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
