Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R

FDA device recall Z-2677-2026 · posted 2026-07-07 · Open, Classified

Recall details

Recalling firm

ConvaTec, Inc

Reason for recall

Surgical dressing manufactured out of specification (greater thickness).

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FRO

Quantity affected

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.

Date initiated

2026-06-08

Date posted

2026-07-07

Location

Greensboro, NC

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