Olympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall
Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip devices due to 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: The product is subject to an FDA Class II recall involving adverse events, which indicates a risk of harm without specific reports of serious injury or death in the provided text.
Plain-English summary
Olympus Corporation of the Americas is initiating a removal of the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip. This action is being taken following continued reports of adverse events.
The affected products include Model TB-0520FC with UDI numbers 04953170370519 and 04953170370502, as well as all other lots. This recall involves worldwide distribution, including the United States, Brazil, Canada, Germany, Mexico, and Japan.
Users should follow the manufacturer's instructions regarding the removal of these devices.
The recalled product
- Product
- Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
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 (4)
- Lot Code: Model: TB-0520FC
- UDI: 04953170370519
- 04953170370502
- 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 →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · adverse events
See all →- HighOlympus Thunderbeat Pistol Grip Medical Device Recalled Due to Adverse Events
FDA (Devices) · 2026-02-25
- HighOlympus Thunderbeat 5 mm 45 cm Front-Actuated Grip Medical Device Recall
FDA (Devices) · 2026-02-25
- HighOlympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events
FDA (Devices) · 2026-02-25
- HighOlympus Thunderbeat 5 mm 35 cm Inline Grip Medical Device Recall
FDA (Devices) · 2026-02-25
Similar recalls
- HighOlympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking
FDA (Devices) · 2025-01-29
- HighOlympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
FDA (Devices) · 2025-01-29
- HighOlympus Thunderbeat surgical instrument probe tips may damage or break
FDA (Devices) · 2025-01-29
- HighOlympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips
FDA (Devices) · 2025-01-29
- HighOlympus Thunderbeat Surgical Hand Instruments Recalled for Probe Damage
FDA (Devices) · 2025-01-29
- HighOlympus Thunderbeat Surgical Instruments Recalled for Probe Tip Damage
FDA (Devices) · 2025-01-29