ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
ConvaTec, Inc., of Greensboro, North Carolina, recalled its Aquacel Ag Surgical SP surgical dressing, REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R, because the dressing was manufactured out of specification with greater thickness. The recall began on June 8, 2026, and was added to the FDA's Enforcement Report on July 7, 2026, covering 4230 units distributed nationwide across 21 states including Maryland, Ohio, Illinois, and others.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- UDI-DI
- 00768455130764
- 00768455130634
- 10768455130631
- Lot
- 5G00809
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Maryland, Ohio, Illinois, North Carolina, Arizona, New York, Minnesota, Texas, Kansas, Tennessee, Indiana, Delaware, Michigan, Florida, Pennsylvania, California, Virginia, Mississippi, New Mexico, Georgia, Colorado.
- Event ID
- 99151
- Recall No.
- Z-2677-2026
- Company
- ConvaTec, IncGreensboro, North Carolina
- Hazard
- Failed specifications
- Quantity recalled
- 4230 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
