FDA DevicesClass II
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Published: July 15, 2026Recall ID: Z-2677-2026Category: devicesCountry: US
Medical DeviceFDA DevicesUS
USAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Recalling Firm: ConvaTec, Inc
Reason for Recall / Hazard
Surgical dressing manufactured out of specification (greater thickness).
Product Description & Identification
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Affected Products
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Additional Source Details
| Field | Value |
|---|---|
| City | Greensboro |
| State | NC |
| Event id | 99151 |
| Address 1 | 7815 National Service Rd Ste 600 |
| Address 2 | N/A |
| Code info | Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631 |
| Postal code | 27409-9403 |
| Report date | 20260715 |
| Product type | Devices |
| Product quantity | 4230 units |
| Reason for recall | Surgical dressing manufactured out of specification (greater thickness). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260608 |
| Initial firm notification | |
| Center classification date | 20260707 |
Overview
- Recalling FirmConvaTec, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.
Recall Hazard Severity
Official Agency AlertHigh Alert (Class I)
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🚨 SAFETY ALERT: ConvaTec, Inc - Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R Check if your household is affected: https://therecallfile.com/recalls/aquacel-ag-surgical-sp-ref-413556-9cm-x-15cm-3-5-in-x-6-in-sterile-r/FDA-Z-2677-2026
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