Olympus recalls Thunderbeat 5mm hand instruments with potential probe tip damage or detachment. Affected units sold with USG-400 or WSG-40:00 generators. No remedy specified in recall notice.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Olympus is recalling Thunderbeat 5mm hand instruments that may have damaged or detached probe tips. This could cause injury during surgery if the instrument fails during use. The recall affects all units sold with specific generators.
The probe tips on these instruments can become damaged or break off during use, potentially causing injury to surgical staff or patients. This risk occurs when the instrument is used with specific surgical generators.
Surgical staff using Olympus Thunderbeat hand instruments with USG-400 or WSG-400 generators. Patients and staff at hospitals using these instruments are most at risk if the probe tips detach during surgery.
Check for model number TB-0545FCS and catalog number N5423510 on the instrument. The recall includes all units sold with USG-400 or WSG-400 generators.
Look for model number TB-0545FCS and catalog number N5423510 on the instrument.
The probe tips may be damaged or breaking, including pad damage and detachment, which could cause injury during surgery.
No remedy is specified in the recall notice, so you do not need to stop using them immediately.
The recall affects instruments used with USG-400 or WSG-400 generators.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1000-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1000-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.