Convex Two-Piece Ostomy System — Class II medical device recall Z-0233-2020
Terminated recall by ConvaTec, Inc, reported 2019-11-06. ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole
| Recall number | Z-0233-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2019-09-06 |
| Classified | 2019-10-29 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2022-11-30 |
| Quantity | 8,008 |
| Lot numbers | 125026, 125027, 125028, 125029, 125030, 125031, 125032, 125033, 125034, 125035, 125036, 125037, 125278, 125279, 125280, 125281, 125282, 125283, 125284, 125285, 125286, 125287, 125288, 125289, 402200, 402201, 402202, 402203, 402204, 402205, 402206, 402207, 402208, 402209, 402210, 402211, 404592, 404593, 404594, 411449 and 460 more |
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
Reason for recall
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.
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-0233-2020. 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.