Agency classClass IIOur severity:High FDA (Devices)·Z-1377-2026·Announced 2026-02-25

Thunderbeat pistol grip devices removed after continued adverse event reports

Olympus is removing the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip 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, 45 cm, Pistol Grip, model number TB-0545PC, 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 30 units under UDI 04953170308635, covering all lots. Distribution was worldwide, covering the United States nationwide and Brazil, Canada, Germany, Mexico 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, 45 cm, Pistol Grip
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical energy device
Hazard: adverse-event-reports
market-removal
Affected units: 30

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-0545PC
UDI: 04953170308635
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 →

Same manufacturer · Olympus Corporation of the Americas

See all →

Moderate
Olympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
Moderate
Olympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
Moderate
Olympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
Severe
Olympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30

Same hazard · adverse event reports