Olympus recalls POWERSEAL 5mm 37cm curved jaw sealers with incomplete seal cycles causing surgery delays. Affected units have model PS-0537CJDA and specific lot numbers. Contact Olympus for remedy.
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 procedures if the device fails to activate correctly.
The device fails to deliver energy after initial activation, causing an incomplete seal cycle. This may delay surgery but does not cause injury or damage to the patient directly.
Surgical teams using the POWERSEAL 5mm 37cm curved jaw sealer for procedures like urology or gynecology are affected. Patients and staff at hospitals using the recalled model are most at risk.
Check for model number PS-0537CJDA and lot numbers CA182543, CA182544, CA182546, CA182548, or CA191230. The device is used in general surgery and specialized procedures.
Verify the model number is PS-0537CJDA and lot numbers match the listed ones.
The model number is PS-0537CJDA.
Lot numbers CA182543, CA182544, CA182546, CA182548, and CA191230 are affected.
The device may not seal properly after initial activation, causing an incomplete seal cycle and no energy delivery.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1700-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1700-2024 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.
