Agency classClass IIOur severity:High FDA (Devices)·Z-1373-2026·Announced 2026-02-25

Thunderbeat Type S devices removed after continued adverse event reports

Olympus is removing the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S from the market, stating the action is due to continued reports of adverse events.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm is removing the device because of continued reports of adverse events, though the record does not describe them or report injuries.

Plain-English summary

The Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S is being recalled by Olympus Corporation of the Americas.

The reason given in the enforcement record is that the firm is initiating a removal due to continued reports of adverse events. The record does not describe the adverse events, so none are set out here.

The record lists 4,181 units. Model numbers, UDI codes and lots are recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Brazil, Canada, Germany and other countries listed in the record. The FDA has classified the action as Class II.

Facilities should stop using the affected devices and follow Olympus' instructions.

The recalled product

Product: Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical energy device
Hazard: adverse-event-reports
market-removal
Affected units: 4,181

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 (5)

Model No. TB-0520FCS
UDI: 04953170383571
0495317083595
04953170383588
All Lots.

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.

See all 12 products in this recall →

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