Olympus recalls POWERSEAL 5mm 44cm curved jaw sealers due to incomplete seal cycles causing surgery delays. Affected units have model PS-0544CJDA and lot code CA179370.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Olympus is recalling POWERSEAL surgical sealers that may not seal properly during surgery, causing delays. This could impact surgical timing and patient care.
The device fails to complete the seal cycle when activated, resulting in no energy delivery to the device. This causes surgery delays but does not cause injury directly.
Surgical teams using the POWERSEAL 5mm 44cm curved jaw sealer for procedures like urology or gynecology. Patients undergoing surgery with this device are at risk of delayed procedures.
Check for model number PS-0544CJDA and lot code CA179370 on the device. These units were sold with the UDI-DI 00821925044579.
Verify if the device emits an incomplete seal cycle tone and shows no energy delivery during activation.
The POWERSEAL device may not complete the seal cycle when activated, causing surgery delays without direct injury.
Check if the device emits an incomplete seal cycle tone and shows no energy delivery during activation. If so, stop using it and contact Olympus for guidance.
No, this issue causes surgery delays but does not result in injury. The hazard is low risk.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1701-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1701-2024 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.
