Agency classClass IIOur severity:High FDA (Devices)·Z-1379-2026·Announced 2026-02-25

Olympus Thunderbeat Grip Medical Device Recall for Adverse Events

Olympus Corporation is recalling 30 Thunderbeat 5 mm, 45 cm Inline Grips due to continued reports of adverse events during medical procedures.

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: FDA Class II medical device recall with reported adverse events, indicating a risk-of-harm product where events have been reported but no hospitalization or serious injury is specified in the source text.

Plain-English summary

Olympus Corporation of the Americas is recalling 30 units of its Olympus Thunderbeat, 5 mm, 45 cm Inline Grip medical device. The recall is being initiated due to continued reports of adverse events associated with use of the device. The affected product has model number TB-0545IC, UDI 04953170308673, and all lots are affected. The recall is worldwide, covering the United States and the countries of Brazil, Canada, Germany, Mexico, and Japan.

The recalled product

Product: Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Instrument
Hazard: device-malfunction
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-0545IC
UDI: 04953170308673
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

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