Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Cygnus Medical First StepBedside ADDWATER Kit Recalled by Cygnus Medical Due to Foreign Object Contamination

Date: March 17, 2016
Company: Cygnus Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cygnus Medical directly.

Affected Products

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).

Quantity: 39 cases of 120 units

Why Was This Recalled?

Foreign material in container

Where Was This Sold?

This product was distributed to 14 states: CA, CO, FL, IL, MN, MT, NY, OH, PA, TX, VT, VA, WA, WI

Affected (14 states)Not affected

About Cygnus Medical

Cygnus Medical has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report