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 Insight

This FDA Devices action (record #Z-1389-2016) was formally reported on April 20, 2016, with the manufacturer initiating the action on March 17, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Cygnus Medical is listed as the recalling firm, operating out of Branford, CT. Federal records indicate 39 cases of 120 units units are affected.

The documented reason for this recall is: Foreign material in container Distribution data in the federal record shows the product reached: US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.