Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported April 20, 2016
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).
Foreign material in container
Cygnus Medical recalled Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexib… - a low-severity action.
Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexib… was recalled by Cygnus Medical in April 20, 2016. Reason: Foreign material in container. Check the official notice for the remedy. Verify recall #Z-1389-2016 with the FDA Devices before acting.
The recall
Cygnus Medical issued this low-severity FDA Devices recall-Foreign material in container.
- Low
- severity level
- Class III
- classification
- April 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1389-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 39 cases of 120 units.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
39 cases of 120 units
Related Recalls
6
3 from same agency
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).
Reason for recall
Foreign material in container
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1389-2016 |
| Date reported | April 20, 2016 |
| Date initiated | March 17, 2016 |
| Recalling firm | Cygnus Medical |
| Firm location | Branford, CT |
| Affected scope | 39 cases of 120 units |
| Distribution | US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1389-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Cygnus Medical. Units affected: 39 cases of 120 units.
Why was this product recalled? ▼
Foreign material in container
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Low. Recall number: Z-1389-2016.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : CA , CO, FL, IL. MN, MT, NY, OH, PA, TX, VA, VT, WA and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1389-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 20, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.