Cook Endoscopy Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Brand
Cook Endoscopy
Lot Codes / Batch Numbers
Product Order Number: FS-OMNI, Lot Number: W2454655.
Products Sold
Product Order Number: FS-OMNI; Lot Number: W2454655.
Cook Endoscopy is recalling Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Sa due to The wire control port of these devices may be missing due to omission of a manufacturing activity.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The wire control port of these devices may be missing due to omission of a manufacturing activity.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026