Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3 — Class II medical device recall Z-2677-2026
Ongoing recall by ConvaTec, Inc, reported 2026-07-15, distributed nationwide. Surgical dressing manufactured out of specification (greater thickness).
| Recall number | Z-2677-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConvaTec, Inc, Greensboro, NC, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-07-07 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 4,230 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00768455130634, 00768455130764, 10768455130631 |
| Lot numbers | 5G00809 |
| Model numbers | 15CM/3.5, 413556, 9CM |
Product
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Reason for recall
Surgical dressing manufactured out of specification (greater thickness).
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-2677-2026. 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.