FDA Medical Device Recalls (openFDA)
Cook Endoscopy: Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
- Recall number
- Z-1598-2009
- Recalling firm
- Cook Endoscopy
- Product
- Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
- Status
- Terminated
- Initiated
- 2009-06-12
- Posted
- 2009-07-21
- Terminated
- 2010-04-06
- Reason
- The wire control port of these devices may be missing due to omission of a manufacturing activity.
- Root cause
- Process control
- Action
- The distributor (Cook Ireland) was instructed to contact their customers and coordinate the return of all recall product to Cook Endoscopy. All devices returned as part of this recall initiative will be dispositioned to scrap and destroyed. Contact the Customer Quality Assurance Department at Cook Endoscopy for more information at cws.complaints@cookmedical.com or 1-336-744-0157.
- Quantity
- 20 units
- Distribution
- International Distribution - Italy, Netherlands, Germany and Spain.
- Lot, serial or model codes
- Product Order Number: FS-OMNI; Lot Number: W2454655.
- 510(k) numbers
- K052051
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- 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