DuoDERM CGF Dressing 10x10CM — Class II medical device recall Z-2519-2021
Ongoing recall by ConvaTec, Inc, reported 2021-09-29. There is a potential for open seals which can compromise sterility.
| Recall number | Z-2519-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2021-08-09 |
| Classified | 2021-09-23 |
| Reported by FDA | 2021-09-29 |
| Countries outside the US | AE, AR, AU, AW, BR, CA, CH, CL, CO, CR, DO, EC, EG, GT, HK, ID, IR, KR, MX, MY, NI, NZ, PA, PE, PK, PY, QA, SG, SV, TH, TW, UY, VN |
| Quantity | 2,734,830 units |
| Reason classes | sterility |
| Lot numbers | 0A03460, 187955, 187957, 9A04124YICC, 9B02984Y, 9G04308, 9H00183, 9H01234, 9H02226, 9H04865, 9J02859, 9K02656, 9K05775, 9L00556, 9L01731, 9L02456ICC, 9L04890, 9M01779 |
Product
DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955)
Reason for recall
There is a potential for open seals which can compromise sterility.
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-2519-2021. 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.