ConvaTec Flexi-Seal SIGNAL Fecal Management System — Class III medical device recall Z-1990-2013
Terminated recall by Convatec Inc., reported 2013-08-28, distributed nationwide. ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related
| Recall number | Z-1990-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Convatec Inc., Skillman, NJ, United States |
| Recall initiated | 2013-06-25 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 22,896 units |
| Reason classes | packaging |
| Lot numbers | 12-FM-01, 12-FM-02 |
Product
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Reason for recall
ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.
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-1990-2013. 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.