FDA Medical Device Recalls (openFDA)
Cygnus Medical: Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
- Recall number
- Z-1389-2016
- Recalling firm
- Cygnus Medical
- Product
- Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).
- Status
- Terminated
- Initiated
- 2016-03-17
- Posted
- not on file
- Terminated
- 2016-05-23
- Reason
- Foreign material in container
- Root cause
- Packaging
- Action
- Cygnus Medical LLC sent an Recall Notice letter certified mail to direct customers and receivers on March 17, 2016. The letter identified the product the problem and the action needed to be taken by the customer. The letter was preceded with an email or fax to expedite notification. Customers to respond via fax or email regarding the quantities in their possession, including a response where the quantity is zero. Returns to made to firm. Contact Quality Manager Cygnus Medical LLC, phone: (203) 488-4554 x 105 fax: (203) 764-1858.Email: qualitycontrol@madpoly.com. For further questions, please call (203) 488-4554.
- Quantity
- 39 cases of 120 units
- Distribution
- US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.
- Lot, serial or model codes
- Lot Numbers: EX20170714A and EX201720A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 3001451466
- Firm city
- Branford
- Firm state
- CT
- 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