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FDAClass II · Medical device · Recalled July 15, 2026
Aquacel Ag Surgical SP REF recall — ConvaTec, Inc
Hazard: Surgical dressing manufactured out of specification (greater thickness).
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2677-2026
- Brand
- ConvaTec
- Classification
- Class II
- Units affected
- 4230 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Affected products
Companies & origin
- Recalling firm location
- Greensboro, NC, United States
- Firm address
- 7815 National Service Rd Ste 600, N/A, 27409-9403
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
- Distribution
- 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.
- Firm notified the public via
- E-Mail
- FDA event ID
- 99151
- Recall initiated
- June 8, 2026
- FDA classified
- July 7, 2026
- FDA report date
- July 15, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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