Cygnus Medical First StepBedside ADDWATER Kit — Class III medical device recall Z-1389-2016
Terminated recall by Cygnus Medical, reported 2016-04-20, distributed in CA, CO, FL, IL, MN, MT, NY, OH…. Foreign material in container
| Recall number | Z-1389-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cygnus Medical, Branford, CT, United States |
| Recall initiated | 2016-03-17 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-05-23 |
| Distributed | CA, CO, FL, IL, MN, MT, NY, OH, PA, TX, VA, VT, WA, WI |
| Reason classes | foreign material |
| Lot numbers | EX20170714A, EX201720A |
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 for recall
Foreign material in container
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1389-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.