Cygnus Medical: Medical Device Recall in 2016 - (Recall #: Z-1389-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class III

Date Initiated: March 17, 2016

Date Posted: April 20, 2016

Recall Number: Z-1389-2016

Event ID: 73568

Reason for Recall:

Foreign material in container

Status: Terminated

Product Quantity: 39 cases of 120 units

Code Information:

Lot Numbers: EX20170714A and EX201720A

Distribution Pattern:

US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated