FDAHealthJune 8, 2026
ConvaTec, Inc — Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
⚠️ Surgical dressing manufactured out of specification (greater thickness).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 8, 2026
US Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX, KS, TN, IN, DE, MI, FL, PA, CA, VA, MS, NM, GA, CO.
What's affected?
- Product
- Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Brand
- ConvaTec, Inc
- Lot code
- /Batch:
Additional details
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4230 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.