Olymp: Olympus POWERSEAL 5MM surgical sealers with model PS-0523CJDA may have a loose rotation collar causing treatment delays. Affected units sold in specific lots.
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Olympus is recalling certain POWERSEAL 5MM surgical sealers that may have a loose rotation collar, which could delay medical treatments. This issue affects devices used in laparoscopic or open surgeries.
The device has a component that doesn't stay properly in place, which might cause the rotation collar to become loose. This could delay medical treatments during surgery but does not cause injury.
Surgical professionals using Olympus POWERSEAL 5MM sealers with model PS-0523CJDA in laparoscopic or open procedures. The risk is low as the hazard only delays treatment, not causing injury.
Check for model number PS-0523CJDA on the device. Affected units were sold with lot numbers CA191167 through CA191170.
Look for model number PS-0523CJDA on the device.
The device has an out of specification component that may cause the rotation collar to become loose, potentially delaying treatment.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The hazard only risks treatment delays, not injury, so the risk level is low.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1813-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1813-2022 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.
