The Recall Desk
HighFDA (Devices)·Z-0108-2024·Announced 2023-10-18

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.

What this means for you

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, Nisse
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Instruments
Hazard
  • control-malfunction

Distribution

Distributed nationwide across the United States.

Related recalls

Same category