FDA Medical Device Recalls (openFDA)
ConvaTec, Inc: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Recall number
- Z-2677-2026
- Recalling firm
- ConvaTec, Inc
- Product
- Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-07
- Terminated
- not on file
- Reason
- Surgical dressing manufactured out of specification (greater thickness).
- 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
- 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.
- Lot, serial or model codes
- Lot/Batch: 5G00809; Primary Pack UDI: (01) 00768455130764/ Secondary Pack UDI: (01) 00768455130634/ Tertiary Pack UDI: (01) 10768455130631
- 510(k) numbers
- ["K152926"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 3011987967
- Firm city
- Greensboro
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28