Olympus recalls ASC PneumoLiner device (Part WA90500US) due to manufacturing error causing wrong tab orientation. This may trap small bowel during surgery, risking injury. Affected units sold in US market only.
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will make tissue encapsulation and bag closure more difficult, introducing the risk of trapping the small bowel/viscera in the bag at closure resulting in patient injury.
Olympus is recalling its ASC PneumoLiner surgical device because a manufacturing error causes the bag's distal tab to be in the wrong orientation. This makes it harder to close the bag properly and could trap small bowel or other organs, potentially causing injury during surgery.
The Pneumoliner bag's distal tab is manufactured in the wrong orientation. This causes the bag to deploy upside down during surgery, making it difficult to seal properly. If the bag doesn't close correctly, small bowel or other organs could become trapped inside, potentially causing injury.
Surgical teams using the ASC PneumoLiner device in the US market. Patients undergoing minimally invasive gynecologic laparoscopic surgery are most at risk if the device is used incorrectly.
Check for the device model number WA90500US. The recall affects units sold in the US market with lot numbers 647572 or 667060.
Verify the model number on your device; affected units have WA90500US.
Reach out to Olympus Corporation of the Americas for specific guidance on affected units.
The device is safe to use if the distal tab is correctly oriented. However, a manufacturing error causes the tab to be in the wrong orientation, which may lead to complications during surgery.
Check your device model number and lot number. If it matches WA90500US with lot 647572 or 667060, contact Olympus for guidance.
Yes, but only if you ensure the distal tab is correctly oriented. The recall addresses a manufacturing error that may cause improper deployment.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0176-2022 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0176-2022 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.
