FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: 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.
- Recall number
- Z-0176-2022
- 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.
- Status
- Terminated
- Initiated
- 2021-09-21
- Posted
- not on file
- Terminated
- 2023-09-08
- Reason
- 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
- 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 laura.storms@olympus.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lots 647572 and 667060
- 510(k) numbers
- ["K192898"]
- PMA numbers
- not on file
- Product code
- PMU
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28