Olympus recalls Thunderbeats laparoscopic surgical tools (model TB-0535FCS) where the blue seal button may stay engaged after release, potentially prolonging surgery. Affected units include specific lot numbers from 2024.
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
Olympus is recalling certain laparoscopic surgical tools (Thunderbeats 5MM, 35CM, Front-actuated Grip Type S) because the blue seal button might stay engaged after being released, which could lead to longer surgery times. This is a safety issue for surgeons using these tools during procedures.
The blue seal button on these tools can remain pressed after release and not return to a neutral position immediately. This could cause the tool to stay engaged during surgery, potentially prolonging the procedure without the surgeon realizing it.
Surgeons and medical professionals who use Olympus Thunderbeats laparoscopic tools with model number TB-0535FCS are most at risk. Patients undergoing surgery with these tools may experience longer procedures due to the button issue.
Check for the model number TB-0535FCS on the tool. Affected units were sold with specific lot numbers listed in the recall notice, including many from 2024. The tools are used in laparoscopic surgery for procedures like appendectomies and hysterectomies.
Look for the model number TB-0535FCS on the Thunderbeats tool to confirm if it's affected.
Reach out to Olympus Corporation of the Americas for assistance with the recall or to get replacement parts if needed.
The blue seal button may stay engaged after release and not return to a neutral position, which could prolong surgery.
Check the model number and lot numbers listed in the recall notice. Contact Olympus for help with the recall.
The hazard could lead to longer surgery times, but it does not pose an immediate risk of injury or death.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0108-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0108-2024 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.
