Aquacel Ag Surgical SP recallZ-2677-2026 · ConvaTec, Inc · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Surgical dressing manufactured out of specification (greater thickness).
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2677-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 7, 2026
- Recalling firm
- ConvaTec, Inc
- Quantity
- 4230 units
- Product code
- FRO
- FDA submissions
- K152926
- 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.
Product description
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Code information (models, lots, serial numbers)
Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AQUACEL AG SURGICAL 413556Convatec, Purchasing Department · Dressing, Wound, Drug1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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