FDA Medical Device Recalls (openFDA)
Olympus America Inc.: Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.
- Recall number
- Z-0829-2012
- Recalling firm
- Olympus America Inc.
- Product
- Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.
- Status
- Terminated
- Initiated
- 2011-12-27
- Posted
- 2012-01-20
- Terminated
- 2013-12-21
- Reason
- Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
- Root cause
- Component design/selection
- Action
- Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.
- Quantity
- not on file
- Distribution
- Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
- Lot, serial or model codes
- Lot numbers 118W, 119W, and 11XW for new inventory
- 510(k) numbers
- K030194
- PMA numbers
- not on file
- Product code
- KNS
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06