Olympus Thunderbeat Surgical Hand Instruments Recalled for Damaged Probe Tips
Olympus has recalled Thunderbeat surgical hand instruments because the probe tips can become damaged or broken, including pad damage and detachment. The recall affects 36,712 units distributed internationally outside the United States.
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 illnesses or injuries. The hazard—damaged or broken probe tips on surgical instruments—poses a risk of harm during surgical procedures but has not yet resulted in reported adverse events.
Plain-English summary
Olympus Corporation of the Americas is recalling the Thunderbeat 5 mm, 20 cm Front-Actuated Grip Type S Hand Instrument (Model TB-0520FCS). This is a sterile, single-use surgical instrument intended for use with Ultrasonic Generators, Electrosurgical Generators, and Thunderbeat Transducers.
The probe tips on these instruments are being damaged or broken, including pad damage and detachment.
The recall involves 36,712 units distributed outside the United States to numerous countries including Canada, Mexico, and throughout Europe, Asia, Africa, and the Middle East. The recall applies to all manufacturing lots.
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: N5424030 Software Version: N/A Product Description: Thunderbeat instrument is a…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 36,712
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: N5424030
- UDI: 04953170383588
- 04953170383585
- 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.
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