Official recall notice
FDA DeviceClass IINotable
FDA Recall: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Recall date
- 2026-07-15
- Brand
- ConvaTec, Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Surgical dressing manufactured out of specification (greater thickness).
Product description
Surgical dressing manufactured out of specification (greater thickness).
Affected products
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631