Olympus Thunderbeat Hand Instruments Recalled for Probe Tip Damage and Breaking
Olympus is recalling Thunderbeat hand instruments because probe tips can be damaged or break, and pads can detach during use. No injuries have been reported.
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 recall with no reported injuries or illnesses. The hazard presents a risk of device failure during surgical procedures, but no actual harm has been reported. This meets the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the Thunderbeat Front-Actuated Grip Type S Hand Instrument (Model TB-0520FCS, Catalog Number N5423930). This sterile, single-use surgical instrument is designed for use with the Ultrasonic Generator (USG-400), Electrosurgical Generator (WSG-400), and Thunderbeat Transducer (TD-TB400) in surgical procedures.
The probe tips of these instruments are being damaged or breaking during use, and the pads can become detached. These failures could compromise instrument function during surgical procedures.
Approximately 84,570 units have been distributed worldwide, including 4,489 units in the United States. The recall affects all lots of Model TB-0520FCS.
Customers who have received these instruments should stop using them and contact Olympus Corporation of the Americas for replacement or return instructions. Healthcare providers should verify their inventory and remove affected units from service.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
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-0520FCS
- Catalog Number/Product Code: N5423930
- UDI: 04953170383571
- 04953170383578
- 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 · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
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 Front-Actuated Grip Medical Device Recall
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 Inline Grip Medical Device Recall
FDA (Devices) · 2026-02-25