SUR-FIT Natura S4S Durahesive Wafer 70MM — Class II medical device recall Z-1134-2022
Terminated recall by ConvaTec, Inc, reported 2022-06-01, distributed nationwide. Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier la
| Recall number | Z-1134-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2022-04-22 |
| Classified | 2022-05-25 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2026-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 600 market |
| UPC / GTIN / UDI-DI | 00768455106189 |
| Lot numbers | 1H02899 |
| Expiration dates | 2026-08-20 |
Product
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Reason for recall
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
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-1134-2022. 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.