Smith & Nephew, Inc. Endoscopy Division DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005
Brand
Smith & Nephew, Inc. Endoscopy Division
Lot Codes / Batch Numbers
Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V.
Products Sold
Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V.
Smith & Nephew, Inc. Endoscopy Division is recalling DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Nu due to The sterility of the device cannot be assured. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The sterility of the device cannot be assured
Recommended Action
Per FDA guidance
Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.
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