Olympus THUNDERBEAT surgical instrument blue seal button may fail to return to neutral
Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.
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 a confirmed control malfunction in a surgical instrument. No injuries or illnesses reported. Classified as High because the device defect poses a risk during surgical procedures, matching the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Olympus Corporation of the Americas is recalling 2,496 units of the THUNDERBEAT Model TB-0535FCS surgical instrument due to a malfunction in the blue seal button.
The blue seal button on affected instruments may remain in the engaged position after release instead of returning to neutral position. This could result in prolonged surgery.
The recalled instruments were distributed nationwide. The devices have UDI-DI: 4953170409677 and specific affected lot numbers are detailed in the official FDA recall notice.
The recalled product
- Product
- THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies…
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 2,496
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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