Olympus recalls specific Thunderbeats surgical tools (model TB-0545FCS) due to a blue seal button that may stay engaged after release, potentially prolonging surgery. Affected units include certain lot numbers for laparoscopic procedures.
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 specific Thunderbeats surgical tools (model TB-0545FCS) that may cause prolonged surgery if the blue seal button stays engaged after being released. This could lead to longer procedures and increased risks for patients during laparoscopic surgeries.
The blue seal button on these tools can remain pressed after release and not return to a neutral position quickly. This may cause the tool to stay engaged longer than intended, potentially prolonging surgery time and increasing risks for patients.
Surgical teams using the recalled Thunderbeats tools for laparoscopic procedures are most at risk. Patients undergoing surgeries with these tools may face longer procedures due to the button issue.
Check for the model number TB-0545FCS on the tool. Affected units include specific lot numbers: KR310806, KR310809, KR313734, KR319658, KR326619, KR326628, KR333661, and KR342666 (added January 11, 2024).
Identify the model number on the tool; affected units are TB-0545FCS with specific lot numbers listed in the recall.
Reach out to Olympus Corporation of the Americas for guidance on next steps or to confirm if your tool is affected.
The recalled model is TB-0545FCS.
Affected lot numbers include KR310806, KR310809, KR313734, KR319658, KR326619, KR326628, KR333661, and KR342666 (added January 11, 2024).
The blue seal button may stay engaged after release and not return to a neutral position quickly, potentially prolonging surgery time.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0109-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0109-2024 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.
