Olympus recalls Thunderbeat 5mm, 35cm hand instruments due to probe tips breaking, causing pad damage and detachment. Affected units have model TB-0535FCS and catalog R5000687.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Olympus is recalling Thunderbeat 5mm, 35cm hand instruments because their probe tips can break, leading to pad damage and detachment. This could cause injury during medical procedures if the instrument fails unexpectedly.
The probe tips of these hand instruments can become damaged or break during use, causing pad damage and detachment. This could lead to the instrument failing unexpectedly during medical procedures, potentially causing injury.
Medical professionals using Olympus Thunderbeat hand instruments for procedures like surgery or dental work are most at risk. Patients using these instruments during procedures may also be affected if the instrument malfunctions.
Check for model number TB-0535FCS and catalog number R5000687 on the instrument packaging or label. These instruments were sold with the UDI numbers 04953170409677 and 04953170383540.
Look for model number TB-0535FCS and catalog number R5000687 on the instrument packaging or label.
The probe tips of the hand instruments can become damaged or broken, causing pad damage and detachment during use.
Check for model number TB-0535FCS and catalog number R5000687 on the instrument packaging or label. These instruments were sold with UDI numbers 04953170409677 and 04953170383540.
The recall record does not specify a remedy, so contact Olympus Corporation of the Americas for further instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0993-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0993-2025 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.
