Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Summary
The FDA issued a Class II for Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R by ConvaTec, Inc. Reason: Surgical dressing manufactured out of specification (greater thickness)..
Details
Source
Device Recall
External ID
Z-2677-2026
Action Date
2026-07-15
Status
Ongoing
Category
device
Product Description
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Lot/Code Info: Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
Quantity Affected: 4230 units
Reason for Recall
Surgical dressing manufactured out of specification (greater thickness).
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-08
Company
Greensboro, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.
ConvaTec, Inc has 19 FDA actions in our database, including 17 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ConvaTec, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ConvaTec, Inc have FDA actions?
ConvaTec, Inc has 19 FDA actions in our database, including 17 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2677-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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