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.
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Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610
“Olympus ASC PneumoLiner device recall: Wrong orientation risks bowel injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61785-olympus-asc-pneumoliner-device-recall-wrong-orientation-risks-bowel-injury. Based on FDA recall #Z-0176-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2022%22&limit=1).
Olympus Corporation of the Americas voluntarily recalled the ASC PneumoLiner device, Part No. WA90500US, due to a manufacturing error that may cause patient injury, the FDA said on Sept. 21, 2021. The recall affects lots 647572 and 667060 distributed nationwide and in Europe.
How to tell if you have it
Brand: Olympus
Product: ASC PneumoLiner device
Part No.: WA90500US (US market only)
Lots: 647572, 667060
The hazard
Due to a manufacturing error, the Pneumoliner Bag Distal Tab exits the Introducer shaft in the wrong orientation. This results in the user deploying the bag upside down, making tissue encapsulation and bag closure more difficult and introducing the risk of trapping the small bowel or viscera in the bag at closure, resulting in patient injury.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls of similar products include Medtronic Octopus Nuvo Tissue Stabilizer Recall: Incorrect Tube Assembly (Jan. 13, 2026), Erbe Medical CleverCap CO2 Tubing/Cap Set Recall: Risk of Water Aspiration Pneumonia (March 31, 2026), and Canon Alphenix INFX-8000C/B5 Recall: Tabletop Shift Risk (Aug. 26, 2026).
How to tell if you have this one
Check for the device model number WA90500US. The recall affects units sold in the US market with lot numbers 647572 or 667060.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number on your device; affected units have WA90500US.
Contact Manufacturer
Reach out to Olympus Corporation of the Americas for specific guidance on affected units.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution to states of: AL, CA, CT, FL, IL, MD, MI, MN, MO, NE, NY, OH, OK, OR, PA, SC, UT, VA, WA, WI, and WV ; and International (foreign) distribution to: Europe.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Connecticut, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0176-2022 (September 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0176-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.