Olympus recalls POWERSEAL 5MM surgical sealers with model PS-0537CJDA due to a loose rotation collar risk. Affected units may delay treatment during surgery.
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 could have a loose rotation collar, potentially delaying treatment during surgery. This is a safety issue for medical professionals using these devices.
The device has an out-of-specification component that prevents the blue retention ring from holding the rotation knob securely. This can cause the rotation collar to become loose, which may delay surgical treatment.
Medical professionals using the Olympus POWERSEAL 5MM surgical sealers with model number PS-0537CJDA are most at risk. Patients undergoing surgery with these devices may experience delayed treatment.
Check for the model number PS-0537CJDA on the device. Affected units were sold with lot numbers CA191233 through CA236290.
Verify the model number on the device is PS-0537CJDA.
Reach out to Olympus Corporation of the Americas for further instructions.
The device may have a loose rotation collar that could delay treatment, so it is not safe to use without checking with Olympus.
Check the model number and contact Olympus Corporation of the Americas for specific instructions.
Affected devices have model number PS-0537CJDA and were sold with lot numbers CA191233 through CA236290.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1814-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1814-2022 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.
