Z-0176-2022Class II

ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a...

Name: Z-0176-2022 ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a...
Creator: Olympus Corporation of the Americas
Published: 2021-09-21
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-09-21 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment... on 2021-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0176-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-21
Posted: 2021-10-26
Terminated: 2023-09-08
Recalling firm: OLYMPUS Corporation of the Americas
Product: ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal.
Product code: PMU Containment System, Laparoscopic Power Morcellation, With Instrument Port
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September 21, 2021, the firm, Olympus, sent an "URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION" letters to affected customers. Customers were instructed to do the following: 1. Immediately assess any affected product you have in stock and quarantine any affected product. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0401 and provide your contact information as indicated in the portal. In addition, if you may have further distributed this product, please identify your customers, notify them at once of this field removal action and appropriately document your notification process. If you require additional information, please contact Global V.P.at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at [email protected].
Quantity in commerce: 350 pieces/70 boxes
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.
Product codes and lots: Lots 647572 and 667060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0176-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0176-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-26

Product code PMU

K192898Class IIPneumoLinerAdvanced Surgical Concepts / cleared 2020-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)