Olympus Thunderbeat Surgical Instrument Recalled for Damaged Probe Tips
Olympus is recalling the Thunderbeat 5 mm surgical hand instrument due to damaged or broken probe tips and pads. The defect may affect surgical function and device performance.
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: This is an FDA Class II recall with no reported injuries, illnesses, or deaths. The defect—damaged or broken probe tips—represents a risk-of-harm product used in surgical procedures. The absence of reported actual harm keeps the severity at High rather than Severe.
Plain-English summary
Olympus Corporation of the Americas is recalling the Thunderbeat Front-Actuated Grip Type S Hand Instrument (Model TB-0545FCS), a sterile, single-use surgical device intended for use with electrosurgical and ultrasonic generators during surgical procedures.
The probe tips of the instruments are being damaged or broken, including pad damage and detachment. This defect may compromise the instrument's functionality during surgical use.
Approximately 4,055 units have been distributed outside the United States to healthcare providers and medical facilities in multiple countries worldwide. All lots of the affected model are included in this recall.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423430 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 4,055
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: TB-0545FCS
- Catalog Number/Product Code: N5423430
- UDI: 04953170383526
- 04953170383523
- Lots: All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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 11 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 · probe damage
See all →- HighCystoscope Outer Sheath Recalled for Potential Laser Probe Damage
FDA (Devices) · 2024-11-20
Similar recalls
- HighOlympus Recalls Thunderbeat Surgical Instruments Due to Component Damage
FDA (Devices) · 2013-12-11
- SevereOlympus Thunderbeat Surgical Device Recall Due to Adverse Events
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 45 cm Front-Actuated Grip Medical Device Recall
FDA (Devices) · 2026-02-25
- HighOlympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall
FDA (Devices) · 2026-02-25
- HighOlympus Thunderbeat Grip Medical Device Recall for Adverse Events
FDA (Devices) · 2026-02-25