Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 25, 2014
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer fe…
Convatec Inc. recalled Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usa… - a critical-severity action.
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usa… was recalled by Convatec Inc. in June 25, 2014. Reason: Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal…. Check the official notice for the remedy. Verify recall #Z-1785-2014 with the FDA Devices before acting.
The recall
Convatec Inc. issued this critical-severity FDA Devices recall-Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal….
- Critical
- severity level
- 73K units
- affected scope
- Class I
- classification
- June 25, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1785-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1785-2014) was formally reported on June 25, 2014, with the manufacturer initiating the action on April 29, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Convatec Inc. is listed as the recalling firm, operating out of Skillman, NJ. Federal records list the affected scope as 73,021 units US; 24,866 units OUS.
The documented reason for this recall is: Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Co… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
73,021 units US; 24,866 units OUS
Related Recalls
6
3 from same agency
Product description
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
Reason for recall
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1785-2014 |
| Date reported | June 25, 2014 |
| Date initiated | April 29, 2014 |
| Recalling firm | Convatec Inc. |
| Firm location | Skillman, NJ |
| Affected scope | 73,021 units US; 24,866 units OUS |
| Distribution | Worldwide Distribution - USA Nationwide |
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-1785-2014) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.. Recalled by Convatec Inc.. Units affected: 73,021 units US; 24,866 units OUS.
Why was this product recalled? ▼
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Critical. Recall number: Z-1785-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1785-2014) 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 June 25, 2014. 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.