Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in. recall (ConvaTec, Inc)
Medical deviceClass IIOngoing
Summary: ConvaTec, Inc is recalling Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R. Reason: Surgical dressing manufactured out of specification (greater thickness).
What is being recalled
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Why
Surgical dressing manufactured out of specification (greater thickness).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia)
How to tell if yours is affected
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2677-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 8, 2026 |
| Reported | July 15, 2026 |
| Company | ConvaTec, Inc |
| Company location | Greensboro, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4230 units |
More recalls from ConvaTec, Inc · all medical device recalls · recalls from June 2026