Class 2 Device Recall AquacelAg Surgical SP

• Date Initiated by Firm: June 08, 2026
• Date Posted: July 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2677-2026
• Recall Event ID: 99151
• 510(K)Number: K152926
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
• Code Information: Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
• FEI Number: 3011987967
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7815 National Service Rd Ste 600; Greensboro NC 27409-9403
• For Additional Information Contact: Media Relations; 336-547-3730
• Manufacturer Reason for Recall: Surgical dressing manufactured out of specification (greater thickness).
• FDA Determined Cause: Nonconforming Material/Component
• Action: On June 8, 2026, Convatec issued a Urgent Medical Device Recall Notification via Email. Convatec asked consignees to take the following actions: Cease use and distribution of the impacted lots; 2. Identify and quarantine any affected product in the inventory. 3. Notify all relevant personel. End users / Patients 1.Discontinue use and dispose of the affected product. 2.Review your personal supplies and determine if you are affected by this communication. 3.Complete response form and return to Convatec within 30-days. Distributors, Wholesalers, Clinical Facilities, & Hospitals. Transmission of Notice & Reporting 4. This notice must be shared with all individuals within your organization who need to be informed, as well as any external organizations to whom the potentially affected devices may have been supplied or transferred. 5.Please ensure continued awareness of this notice and the associated actions for an appropriate period, so that the corrective measures remain effective across your organization. 6. All device-related incidents or complaints should be reported to the manufacturer, distributor, or local representative. Such reporting provides essential feedback for ongoing safety monitoring.
• Quantity in Commerce: 4230 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRO