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Olympus Thunderbeat II Shears
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MEDICAL DEVICE RECALLMODERATE

Olympus Thunderbeat II Shears

Olympus recalls Thunderbeat II Shears (model TB2-0520FC) over distal tip detachment risk.

What to do

Stop using the affected device immediately. Contact Olympus Corporation of the Americas for instructions on returning the device and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-1854-2026
Agency
FDA
Firm
Olympus Corporation of the Americas
Recall ID
98550
Status
ONGOING

Why it was recalled

Olympus is recalling the Thunderbeat II Shears with Ultrasonic Mode, 5mm, 20cm, model TB2-0520FC, due to the potential for detachment of a distal tip component during use, which could cause serious injury. The affected device is used in surgical procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Olympus Thunderbeat II Shears w Ultrasonic Mode, 5mm

ProductModel
20cm.TB2-0520FC
25cm.TB2-0525FC
35cm.TB2-0535FC
45cm.TB2-0545FC

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification