FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006
- Recall number
- Z-2078-2009
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction Catalog Number: 7211006
- Status
- Terminated
- Initiated
- 2009-05-27
- Posted
- 2009-09-21
- Terminated
- 2012-05-08
- Reason
- The sterility of the device cannot be assured
- Root cause
- Package design/selection
- Action
- 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.
- Quantity
- 67,697 units
- Distribution
- Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
- Lot, serial or model codes
- 0169H, 0299J, 0409K, 0409L, 0409M, 0479U, 0479X, 0489F, 0489H, 0859F, 0899J, 0919F, 1618F, 1618L, 1618LR, 1628F, 1628FR, 1648K, 1648KR, 1758J,1838K, 1908M, 1938F, 2058L, 2528F, 2528FR, 2558F, 2698J, 2748F, 2748P, 2808U, 2838L, 2848H, 2878N, 2908U, 2908V, 3038N, 3048M, and 3258P.
- 510(k) numbers
- ["K051326"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- 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