FDA Device recall Z-1389-2016
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile
- FDA Device
- Class III
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class III recall of Cygnus Medical First StepBedside ADDWATER Kit,non-sterile by Cygnus Medical, citing foreign material in container.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1389-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-03-17 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cygnus Medical |
| Distribution | CA, CO, FL, IL, MN, MT, NY, OH, PA, TX, VA, VT, WA, WI |
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).
Reason
Foreign material in container
Identifiers
| code_info | Lot Numbers: EX20170714A and EX201720A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2016%22
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