Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.
Brand
Smith & Nephew, Inc. Endoscopy Division
Lot Codes / Batch Numbers
Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F.
Products Sold
Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F.
Smith & Nephew, Inc. Endoscopy Division is recalling DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Dispos due to Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
Recommended Action
Per FDA guidance
Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008. Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026