Z-2677-2026Class II

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

Name: Z-2677-2026 Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Creator: ConvaTec, Inc
Published: 2026-06-08
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2026-06-08 / Open, Classified / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R on 2026-06-08. FDA classified it as Class II and gives the reason as "Surgical dressing manufactured out of specification (greater thickness)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2677-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-07
Recalling firm: ConvaTec Limited
Product: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Product code: FRO Dressing, Wound, Drug
Reason for recall: Surgical dressing manufactured out of specification (greater thickness).
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2677-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2677-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-07

Product code FRO

K152926UnclassifiedAQUACEL Ag Surgical SP DressingConvatec Limited / cleared 2016-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)