FDA Medical devices recall ·
Aquacel Ag Surgical SP recall
- Recall number
- Z-2677-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- ConvaTec, Inc
7815 National Service Rd Ste 600, Greensboro, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4230 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Why was it recalled?
Surgical dressing manufactured out of specification (greater thickness).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Arizona California Colorado Delaware Florida Georgia Illinois Indiana Kansas Maryland Michigan Minnesota Mississippi North Carolina New Mexico New York Ohio Pennsylvania Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2677-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.