Class II — ConvaTec, Inc
| Recalling firm | ConvaTec |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring. |
| Product | Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management |
| Quantity | 8,008131 skin barriers |
| Distribution | Worldwide distributions. |
| Initiated | 2019-09-06 |
| Classified | 2019-10-29 |
| Terminated | 2022-11-30 |
| Recall number | Z-0233-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ConvaTec, Inc (Z-0233-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83993/
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