ConvaTec CarboFlex — Class II medical device recall Z-1495-2024
Ongoing recall by ConvaTec, Inc, reported 2024-04-17, distributed nationwide. The product does not meet sterility assurance level.
| Recall number | Z-1495-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2024-02-27 |
| Classified | 2024-04-08 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Quantity | 63 market |
| Reason classes | sterility |
| Lot numbers | 3J00675, 3J02320, 3J02332, 3L04811, 4A00343 |
Product
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Reason for recall
The product does not meet sterility assurance level.
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-1495-2024. 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.