Olympus Thunderbeat Surgical Device Recall Over Adverse Events
Olympus is recalling 1,538 Thunderbeat 5 mm surgical devices worldwide due to continued reports of adverse events. The recall affects all units of Model No. TB-0510IC.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a medical device with continued reports of adverse events. Per the rubric, FDA Class II recalls with reported adverse events or risk-of-harm products warrant a severity score of 4 (Severe).
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat 5 mm, 10 cm, Inline Grip surgical device due to continued reports of adverse events. The recall covers all units of Model No. TB-0510IC with UDI 04953170308734.
A total of 1,538 units are included in this recall. The devices were distributed worldwide, including US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Healthcare facilities and users who have the affected devices should follow their institution's procedures for managing recalled medical devices. Questions can be directed to Olympus Corporation of the Americas.
This is a Class II recall as classified by the FDA. The recall number is Z-1382-2026.
The recalled product
- Product
- Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,538
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. TB-0510IC
- UDI: 04953170308734
- All Units.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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